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© 2005 by the American College of Cardiology Foundation and the American Heart Association, Inc.

ACC/AHA/SCAI PRACTICE GUIDELINES—FULL TEXT (Track Change Version)*



ACC/AHA/SCAI 2005 Guideline Update for
Percutaneous Coronary Intervention
A Report of the American College of Cardiology/American Heart Association Task
Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001
Guidelines for Percutaneous Coronary Intervention)


                                                 WRITING COMMITTEE MEMBERS
                                                Sidney C. Smith, Jr, MD, FACC, FAHA, Chair
Ted E. Feldman, MD, FACC, FSCAI†                                                    Douglass A. Morrison, MD, PhD, FACC, FSCAI†
John W. Hirshfeld, Jr, MD, FACC, FSCAI†                                             William W. O’Neill, MD, FACC, FSCAI
Alice K. Jacobs, MD, FACC, FAHA, FSCAI                                              Hartzell V. Schaff, MD, FACC, FAHA
Morton J. Kern, MD, FACC, FAHA, FSCAI†                                              Patrick L. Whitlow, MD, FACC, FAHA
Spencer B. King, III, MD, MACC, FSCAI                                               David O. Williams, MD, FACC, FAHA, FSCAI



                                                           TASK FORCE MEMBERS
                                              Elliott M. Antman, MD, FACC, FAHA, Chair
                                           Sidney C. Smith, Jr., MD, FACC, FAHA, Vice Chair
Cynthia D. Adams, MSN, APRN-BC, FAHA                                                Sharon Ann Hunt, MD, FACC, FAHA
Jeffrey L. Anderson, MD, FACC, FAHA                                                 Alice K. Jacobs, MD, FACC, FAHA
David P. Faxon, MD, FACC, FAHA‡                                                     Rick Nishimura, MD, FACC, FAHA
Valentin Fuster, MD, PhD, FACC, FAHA, FESC‡                                         Joseph P. Ornato, MD, FACC, FAHA
Jonathan L. Halperin, MD, FACC, FAHA                                                Richard L. Page, MD, FACC, FAHA
Loren F. Hiratzka, MD, FACC, FAHA‡                                                  Barbara Riegel, DNSc, RN, FAHA


*Changes in the recommendations from the 2001 guidelines to the 2005 guide-         Guidelines for Percutaneous Coronary Intervention). American College of
  line update are reflected by strike-through showing deleted text and under-       Cardiology Web Site. Available at: http://www.acc.org/clinical/guidelines/per-
  lining showing new text.                                                          cutaneous/update/index_rev.pdf.
†SCAI Official Representative
‡Former Task Force Member during this writing effort                                Copies: This document is available on the World Wide Web sites of the
                                                                                    American College of Cardiology (www.acc.org), the American Heart
Acknowledgement: The ACC and AHA recognize Dr J. Ward Kennedy for his               Association (www.americanheart.org), and the Society for Cardiovascular
dedicated service on developing ACC/AHA guidelines for PTCA and PCI since           Angiography and Interventions (www.scai.org). Single copies of this document
their inception in 1986 and for his counsel and advice in the preparation of this   are available by calling 1-800-253-4636 or writing the American College of
guideline.                                                                          Cardiology Foundation, Resource Center, at 9111 Old Georgetown Road,
                                                                                    Bethesda, MD 20814-1699. Ask for reprint number 71-0347. To obtain a copy
This document was approved by the American College of Cardiology                    of the Summary Article published in the January 3, 2006 issue of the Journal
Foundation Board of Trustees in August 2005, by the American Heart                  of the American College of Cardiology, the January 3, 2006 issue of
Association Science Advisory and Coordinating Committee in August 2005,
                                                                                    Circulation, and the January 2006 issue of Catheterization and Cardiovascular
and by the Society for Cardiovascular Angiography and Interventions Board of
                                                                                    Interventions, ask for reprint number 71-0346. To purchase bulk reprints (spec-
Trustees in August 2005.
                                                                                    ify version and reprint number): Up to 999 copies, call 1-800-611-6083 US
When citing this document, the American College of Cardiology Foundation            only) or fax 413-665-2671; 1000 or more copies, call 214-706-1789, fax 214-
requests that the following citation format be used: Smith SC Jr, Feldman TE,       691-6342, or e-mail pubauth@heart.org.
Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB III, Morrison DA, O’Neill WW,
Schaff HV, Whitlow PL, Williams DO. ACC/AHA/SCAI 2005 guideline                     Permissions: Multiple copies, modification, alteration, enhancement, and/or
update for percutaneous coronary intervention: a report of the American             distribution of this document are not permitted without the express permission
College of Cardiology/American Heart Association Task Force on Practice             of the American College of Cardiology Foundation. Please direct requests to
Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001                       copyright_permissions@acc.org.
ACC - www.acc.org
           Smith et al. 2005                                                                                                                    AHA - www.americanheart.org
2          ACC/AHA/SCAI Practice Guidelines                                                                                                             SCAI - www.scai.org

                      TABLE OF CONTENTS                                                               5.5.2. Late Ischemia After CABG................................ 57
                                                                                                      5.5.3. Early and Late Outcomes of Percutaneous
PREAMBLE.............................................................................. 3                     Intervention........................................................ 58
1. INTRODUCTION................................................................. 3                    5.5.4. General Considerations...................................... 58
                                                                                                 5.6. Use of Adjunctive Technology (Intracoronary
2. GENERAL CONSIDERATIONS AND
                                                                                                      Ultrasound Imaging, Flow Velocity, and Pressure)......58
   BACKGROUND................................................................... 6
                                                                                                      5.6.1. Intravascular Ultrasound Imaging......................58
3. OUTCOMES......................................................................... 7                5.6.2. Coronary Artery Pressure and Flow: Use of
   3.1. Definitions of PCI Success.............................................7                             Fractional Flow Reserve and Coronary
        3.1.1. Angiographic Success .......................................... 7                             Vasodilatory Reserve..........................................60
        3.1.2. Procedural Success...............................................7
        3.1.3. Clinical Success................................................... 7          6. MANAGEMENT OF PATIENTS UNDERGOING PCI.... 61
   3.2. Acute Outcome: Procedural Complications................... 7                             6.1. Evolution of Technologies............................................61
   3.3. Acute Outcome: Success Rates.................................... 11                           6.1.1. Acute Results......................................................62
   3.4. Long-Term Outcome and Restenosis........................... 11                                6.1.2. Late-Term Results.............................................. 62
   3.5. Predictors of Success/Complications .......................... 12                        6.2. Antiplatelet and Antithrombotic Adjunctive
        3.5.1. Lesion Morphology and Classification.............. 12                                  Therapies For PCI........................................................ 62
               3.5.1.1. Clinical Factors..................................... 13                      6.2.1. Oral Antiplatelet Therapy................................... 62
               3.5.1.2. Left Main CAD..................................... 15                         6.2.2. Glycoprotein IIb/IIIa Inhibitors......................... 66
        3.5.2. Risk of Death..................................................... 18                         6.2.2.1. Abciximab............................................. 67
        3.5.3. Women................................................................18                       6.2.2.2. Eptifibatide............................................ 69
        3.5.4. The Elderly Patient.............................................20                            6.2.2.3. Tirofiban................................................ 70
        3.5.5. Diabetes Mellitus............................................... 20                    6.2.3. Antithrombotic Therapy..................................... 70
        3.5.6. PCI After Coronary Artery Bypass Surgery.......21                                             6.2.3.1. Unfractionated Heparin, Low-Molecular-
        3.5.7. Specific Technical Considerations..................... 21                                             Weight Heparin, and Bivalirudin...........70
        3.5.8. Issues of Hemodynamic Support in                                                              6.2.3.2. Heparin Dosing Guidelines...................72
               High-Risk PCI.................................................... 22              6.3. Post-PCI Management..................................................72
   3.6. Comparison With Bypass Surgery................................22                              6.3.1. Postprocedure Evaluation of Ischemia...............73
   3.7. Comparison With Medicine......................................... 24                          6.3.2. Risk Factor Modifications..................................74
4. INSTITUTIONAL AND OPERATOR COMPETENCY.... 29                                                       6.3.3. Exercise Testing After PCI.................................74
   4.1. Quality Assurance.........................................................29                  6.3.4. Left Main CAD.................................................. 74
   4.2. Operator and Institutional Volume............................... 31                   7. SPECIAL CONSIDERATIONS.......................................... 78
   4.3. Role of Onsite Cardiac Surgical Back-up.................. 35                             7.1. Ad Hoc Angioplasty—PCI at the Time of Initial
   4.4. Primary PCI for STEMI Without Onsite Cardiac                                                  Cardiac Catheterization................................................ 78
        Surgery..........................................................................37      7.2. PCI in Cardiac Transplant Patients.............................. 79
   4.5. Elective PCI Without Onsite Surgery...........................39
                                                                                                 7.3. Clinical Restenosis: Background and Management.....79
5. CLINICAL PRESENTATIONS.......................................... 39                                7.3.1. Background on Restenosis After PTCA............ 79
   5.1. Patients With Asymptomatic Ischemia or CCS                                                    7.3.2. Clinical and Angiographic Factors for Restenosis
        Class I or II Angina...................................................... 40                        After PTCA........................................................ 79
   5.2. Patients With CCS Class III Angina............................ 41                             7.3.3. Management Strategies for Restenosis After
   5.3. Patients With UA/NSTEMI..........................................42                                  PTCA..................................................................81
   5.4. Patients With STEMI................................................... 43                     7.3.4. Background on Restenosis After BMS
        5.4.1. General and Specific Considerations................. 43                                       Implantation....................................................... 81
        5.4.2. PCI in Fibrinolytic-Ineligible Patients............... 51                              7.3.5. Drug-Eluting Stents............................................82
        5.4.3. Facilitated PCI....................................................51                  7.3.6. Management Strategies for ISR......................... 87
        5.4.4. PCI After Failed Fibrinolysis (Rescue PCI)...... 51                                           7.3.6.1. PTCA.....................................................87
        5.4.5. PCI After Successful Fibrinolysis or for                                                      7.3.6.2. Drug-Eluting Stents...............................87
               Patients Not Undergoing Primary Reperfusion. 53                                               7.3.6.3. Radiation............................................... 88
        5.4.6. PCI for Cardiogenic Shock................................ 54                                  7.3.6.4. Medical Therapy....................................88
        5.4.7. PCI in Selected Patient Subgroups.................... 55                               7.3.7. Subacute Stent Thrombosis................................90
               5.4.7.1. Young and Elderly Postinfarct Patients.55                                     7.3.8. Drug-Eluting Stents: Areas Requiring Further
               5.4.7.2. Patients With Prior MI.......................... 56                                  Investigation....................................................... 90
   5.5. Percutaneous Intervention in Patients With Prior
                                                                                                 7.4. Cost-Effectiveness Analysis for PCI............................ 90
        Coronary Bypass Surgery.............................................56
        5.5.1. Early Ischemia After CABG...............................57                     8. FUTURE DIRECTIONS..................................................... 91
ACC - www.acc.org
 AHA - www.americanheart.org                                                                                                        Smith et al. 2005
 SCAI - www.scai.org                                                                                                ACC/AHA/SCAI Practice Guidelines        3

Appendix 1. Relationships With Industry: Writing                                               nosis, management, or prevention of specific diseases or
           Committee............................................................92             conditions. These guidelines attempt to define practices that
Appendix 2. Relationships With Industry: Peer                                                  meet the needs of most patients in most circumstances. These
           Reviewers............................................................ 93            guideline recommendations reflect a consensus of expert
                                                                                               opinion after a thorough review of the available, current sci-
References................................................................................94
                                                                                               entific evidence and are intended to improve patient care. If
                                                                                               these guidelines are used as the basis for regulatory/payer
                                                                                               decisions, the ultimate goal is quality of care and serving the
PREAMBLE
                                                                                               patient’s best interests. The ultimate judgment regarding care
It is important that the medical profession play a significant                                 of a particular patient must be made by the healthcare
role in critically evaluating the use of diagnostic procedures                                 provider and patient in light of all of the circumstances pre-
and therapies as they are introduced and tested in the detec-                                  sented by that patient.
tion, management, or prevention of disease states. Rigorous                                      These guidelines were approved for publication by the gov-
and expert analysis of the available data documenting rela-                                    erning bodies of the ACCF, AHA, and SCAI. The guidelines
tive benefits and risks of those procedures and therapies can                                  will be reviewed annually by the ACC/AHA Task Force on
produce helpful guidelines that improve the effectiveness of                                   Practice Guidelines and will be considered current unless
care, optimize patient outcomes, and favorably affect the                                      they are revised or withdrawn from distribution. The sum-
overall cost of care by focusing resources on the most effec-                                  mary article and recommendations are published in the
tive strategies.                                                                               January 3, 2006 issue of the Journal of the American College
  The American College of Cardiology (ACC) and the                                             of Cardiology, the January 3, 2006 issue of Circulation, and
American Heart Association (AHA) have jointly engaged in                                       the January 2006 issue of Catheterization and Cardio-
the production of such guidelines in the area of cardiovascu-                                  vascular Interventions. The full-text guideline is posted on
lar disease since 1980. This effort is directed by the                                         the World Wide Web sites of the ACC (www.acc.org), the
ACC/AHA Task Force on Practice Guidelines, whose charge                                        AHA (www.americanheart.org),               and    the    SCAI
is to develop and revise practice guidelines for important car-                                (www.scai.org). Copies of the full text and the executive
diovascular diseases and procedures. The Task Force is                                         summary are available from the ACC, AHA, and the SCAI.
pleased to have this guideline cosponsored by the Society for
Cardiovascular Angiography and Interventions (SCAI).                                           Elliott M. Antman, MD, FACC, FAHA
Experts in the subject under consideration have been select-                                   Chair, ACC/AHA Task Force on Practice Guidelines
ed from all three organizations to examine subject-specific
data and write guidelines. The process includes additional
representatives from other medical practitioner and specialty                                  1. INTRODUCTION
groups where appropriate. Writing groups are specifically
charged to perform a formal literature review, weigh the                                       The ACC/AHA Task Force on Practice Guidelines was
strength of evidence for or against a particular treatment or                                  formed to gather information and make recommendations
procedure, and include estimates of expected health out-                                       about appropriate use of technology for the diagnosis and
comes where data exist. Patient-specific modifiers, comor-                                     treatment of patients with cardiovascular disease.
bidities, and issues of patient preference that might influence                                Percutaneous coronary interventions (PCIs) are an important
the choice of particular tests or therapies are considered, as                                 group of technologies in this regard. Although initially limit-
well as frequency of follow-up and cost-effectiveness. When                                    ed to balloon angioplasty and termed percutaneous translu-
available, information from studies on cost will be consid-                                    minal coronary angioplasty (PTCA), PCI now includes other
ered; however, review of data on efficacy and clinical out-                                    new techniques capable of relieving coronary narrowing.
comes will be the primary basis for preparing recommenda-                                      Accordingly, in this document, implantation of intracoronary
tions in these guidelines.                                                                     stents and other catheter-based interventions for treating
  The ACC/AHA Task Force on Practice Guidelines makes                                          coronary atherosclerosis are considered components of PCI.
every effort to avoid any actual, potential, or perceived con-                                 In this context, PTCA will be used to refer to those studies
flicts of interest that might arise as a result of an outside rela-                            using only balloon angioplasty, whereas PCI will refer to the
tionship or personal interest of a member of the writing                                       broader group of percutaneous techniques. These new tech-
panel. Specifically, all members of the writing panel are                                      nologies have impacted the effectiveness and safety profile
asked to provide disclosure statements of all such relation-                                   initially established for balloon angioplasty. Moreover, addi-
ships that might be perceived as real or potential conflicts of                                tional experience has been gained in the use of adjunctive
interest. These statements are reviewed by the parent task                                     pharmacological treatment with glycoprotein (GP) IIb/IIIa
force, reported orally to all members of the writing panel at                                  receptor antagonists and the use of bivalirudin, thienopy-
each meeting, and updated and reviewed by the writing com-                                     ridines, and drug-eluting stents (DES). In addition, since
mittee as changes occur.                                                                       publication of the guidelines in 2001, greater experience in
  The practice guidelines produced are intended to assist                                      the performance of PCI in patients with acute coronary syn-
healthcare providers in clinical decision making by describ-                                   dromes and in community hospital settings has been gained.
ing a range of generally acceptable approaches for the diag-                                   In view of these developments, an update of these guidelines
ACC - www.acc.org
          Smith et al. 2005                                                                               AHA - www.americanheart.org
4         ACC/AHA/SCAI Practice Guidelines                                                                        SCAI - www.scai.org

is warranted. This document reflects the opinion of the             are not available, there may be a very clear clinical consen-
ACC/AHA/SCAI writing committee charged with updating                sus that a particular test or therapy is useful and effective.
the 2001 guidelines for PCI (1).                                      In instances where recommendations of class III, level of
  Several issues relevant to the Writing Committee’s process        evidence C, occur, it is recognized that the bases of these rec-
and the interpretation of the guidelines have been noted pre-       ommendations are opinion and the consensus of the writing
viously and are worthy of restatement. First, PCI is a tech-        group. In this setting, it is not unreasonable for clinical trials
nique that has been continually refined and modified; hence,        to be conducted to further investigate the validity of this con-
continued, periodic guideline revision is anticipated. Second,      sensus opinion. The schema for classification of recommen-
these guidelines are to be viewed as broad recommendations          dations and level of evidence is summarized in Table 1,
to aid in the appropriate application of PCI. Under unique          which also illustrates how the grading system provides an
circumstances, exceptions may exist. These guidelines are           estimate of the size of the treatment effect and an estimate of
intended to complement, not replace, sound medical judg-            the certainty of the treatment effect.
ment and knowledge. They are intended for operators who               The committee conducted comprehensive searching of the
possess the cognitive and technical skills for performing PCI       scientific and medical literature on PCI, with special empha-
and assume that facilities and resources required to properly       sis on randomized controlled trials and meta-analyses pub-
perform PCI are available. As in the past, the indications are      lished since 2001. In addition to broad-based searching on
categorized as class I, II, or III on the basis of a multifactor-   PCI, specific targeted searches were performed on the fol-
ial assessment of risk and expected efficacy viewed in the          lowing subtopics: catheter-based intervention, stents (drug-
context of current knowledge and the relative strength of this      eluting and bare-metal), cardiac biomarkers (e.g., creatine
knowledge.                                                          kinase and troponins), pharmacological therapy (aspirin,
  These classes summarize the recommendations for proce-            thienopyridines, GP IIb/IIIa inhibitors, heparin, and direct
dures or treatments as follows:                                     thrombin inhibitors), special populations (women, patients
                                                                    with diabetes, elderly), coronary artery bypass grafting
    Class I: Conditions for which there is evidence for             (CABG), high-risk PCI, quality, outcomes, volume, left main
             and/or general agreement that a given proce-           PCI (protected and unprotected), distal embolic protection,
             dure or treatment is beneficial, useful, and           intravascular ultrasound (IVUS), fractional flow reserve
             effective.                                             (FFR), vascular closure, and secondary prevention/risk fac-
                                                                    tor modification. The complete list of keywords is beyond
    Class II: Conditions for which there is conflicting evi-
                                                                    the scope of this section. The committee reviewed all com-
              dence and/or a divergence of opinion about
                                                                    piled reports from computerized searches and conducted
              the usefulness/efficacy of a procedure or
                                                                    additional searching by hand. Literature citations were gen-
              treatment.
                                                                    erally restricted to published manuscripts appearing in jour-
              Class IIa: Weight of evidence/opinion is in           nals listed in Index Medicus. Because of the scope and
              favor of usefulness/efficacy.                         importance of certain ongoing clinical trials and other emerg-
                                                                    ing information, published abstracts were cited when they
              Class IIb: Usefulness/efficacy is less well           were the only published information available. Additionally,
              established by evidence/opinion.                      the Committee reviewed and incorporated recommendations
Class III: Conditions for which there is evidence and/or            and/or text from published ACC/AHA or SCAI documents to
           general agreement that a procedure/treat-                maintain consistency, as appropriate.
           ment is not useful/effective and in some cases             Initially, this document describes the background informa-
           may be harmful.                                          tion that forms the foundation for specific recommendations.
                                                                    Topics fundamental to coronary intervention are reviewed,
 In addition, the weight of evidence in support of the rec-         followed by separate discussions relating to unique technical
ommendation is listed as follows:                                   and operational issues. This format is designed to enhance
                                                                    the usefulness of this document for the assessment and care
• Level of Evidence A: Data derived from multiple random-           of patients with coronary artery disease (CAD). Formal rec-
     ized clinical trials or meta-analyses.                         ommendations for the use of PCI according to clinical pres-
                                                                    entation are included in Section 5. A clear distinction is
• Level of Evidence B: Data derived from a single random-           drawn between the emergency use of PCI for patients with
     ized trial or nonrandomized studies.
                                                                    ST-segment elevation myocardial infarction (STEMI),
• Level of Evidence C: Only consensus opinion of experts,           termed “primary PCI,” and all other procedures, which are
     case studies, or standard-of-care.                             included under the term “elective PCI” (see Section 4.2 for
                                                                    further discussion).
  A recommendation with level of evidence B or C does not             This committee includes cardiologists with and without
imply that the recommendation is weak. Many important               involvement in interventional procedures, and a cardiac sur-
clinical questions addressed in the guidelines do not lend          geon. This document was reviewed by 2 official reviewers
themselves to clinical trials. Even though randomized trials        nominated by ACC; 2 official reviewers nominated by AHA;
Table 1. Applying Classification of Recommendations and Level of Evidence
                                                                      “Size of Treatment Effect”
                                                                                                                                                                                                                                                        ACC - www.acc.org

                                                                                                                                                                                                                                                        SCAI - www.scai.org
                                                                                                                                                                                                                                                        AHA - www.americanheart.org




      *Data available from clinical trials or registries about the usefulness/efficacy in different sub-populations, such as gender, age, history of diabetes, history of prior MI, history of heart failure, and prior aspirin use. A recommendation
      with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomized trials are not available,
      there may be a very clear clinical consensus that a particular test or therapy is useful or effective.
                                                                                                                                                                                                                                                                        Smith et al. 2005
                                                                                                                                                                                                                                                        ACC/AHA/SCAI Practice Guidelines




      †In 2003, the ACC/AHA Task Force on Practice Guidelines developed a list of suggested phrases to use when writing recommendations. All recommendations in this guideline have been written in full sentences that express a complete
      thought, such that a recommendation, even if separated and presented apart from the rest of the document (including headings above sets of recommendations), would still convey the full intent of the recommendation. It is hoped that
      this will increase readers’ comprehension of the guidelines and will allow queries at the individual recommendation level.
                                                                                                                                                                                                                                                        5
ACC - www.acc.org
         Smith et al. 2005                                                                                  AHA - www.americanheart.org
6        ACC/AHA/SCAI Practice Guidelines                                                                           SCAI - www.scai.org

2 official reviewers nominated by SCAI; 1 official reviewer             The value of coronary angioplasty was further defined by
from the ACC/AHA Task Force on Practice Guidelines; and               comparing its results to those of alternative methods of treat-
8 content reviewers, including members from the AHA                   ment. Randomized clinical trials have assessed the outcomes
Committee on Diagnostic and Interventional Cardiac                    of patients treated by a strategy of initial angioplasty to one
Catheterization and the ACCF Cardiac Catheterization and              of medical therapy alone or to coronary artery bypass surgery
Intervention Committee.                                               (10-14). The results of these trials have clarified the utility of
                                                                      angioplasty in terms of effectiveness, complications, and
2. GENERAL CONSIDERATIONS AND                                         patient selection. The technique of coronary angioplasty has
BACKGROUND                                                            also been expanded by the development of devices that
Coronary angioplasty was first introduced by Andreas                  replace or serve as adjuncts to the balloon catheter. These
Gruentzig in 1977 (2) as a nonsurgical method for coronary            “new devices” have been evaluated and have had a variable
arterial revascularization. Fundamentally, the technique              impact in enhancing the immediate- and long-term efficacy
involved advancing a balloon-tipped catheter to an area of            and safety of coronary angioplasty. The following section of
coronary narrowing, inflating the balloon, and then removing          this report expands on this background and describes the
the catheter after deflation. Early reports demonstrated that         practice of PCI as it is applied today.
balloon angioplasty could reduce the severity of coronary               Advances in coronary-based interventions, especially the
stenosis and diminish or eliminate objective and subjective           use of bare-metal stents (BMS) and drug-eluting stents
manifestations of ischemia (3-5). Although angioplasty was            (DES), have improved the efficacy and safety profile of per-
clearly feasible and effective, the scope of coronary disease         cutaneous revascularization observed for patients undergo-
to be treated was quite narrow. Also, because angioplasty             ing PTCA. For example, stents reduce both the acute risk of
could result in sudden arterial occlusion and subsequent              major complications and late-term restenosis. The success of
myocardial infarction (MI), immediate access to coronary              new coronary devices in meeting these goals is reflected in
bypass surgery was essential (6). With experience and time,           part by the rapid transition from the use of PTCA alone (less
however, the cognitive and technical aspects as much as the           than 30%) to the high use of PCI with stenting, which was
equipment used to perform angioplasty became more                     greater than 70% by the late 1990s (Figure 1) (15).
refined. Observational reports of large numbers of patients           Atherectomy devices and stenting, associated with improved
confirmed that coronary angioplasty could be applied to               acute angiographic and clinical outcomes compared with
broad groups of coronary patients with higher rates of suc-           PTCA alone in specific subsets, continue to be applied to a
cess and lower rates of complications than seen in initial            wider patient domain that includes multivessel disease and
experiences (7,8). More than 1 000 000 PCI procedures are             complex coronary anatomy. However, strong evidence (level
performed yearly in the United States (9), and it has been            A data from multiple randomized clinical trials) is primarily
estimated that nearly 2 000 000 procedures are performed              available for stenting over PTCA in selected patients under-
annually worldwide.                                                   going single-vessel PCI.




    Figure 1. Frequency of device use in the SCAI registry. Source data from Laskey et al. Catheter Cardiovasc Interv 2000;49:19-22
    (15).
ACC - www.acc.org
AHA - www.americanheart.org                                                                           Smith et al. 2005
SCAI - www.scai.org                                                                   ACC/AHA/SCAI Practice Guidelines       7

  The range of non-balloon revascularization technology          Although the occurrence of emergency coronary artery
approved by the Food and Drug Administration (FDA) for           bypass surgery and death are easily identified end points, the
use in native and/or graft coronary arteries includes balloon    definition of procedure-related MI has been debated. The
expandable stents, DES, extraction atherectomy, directional      development of Q waves in addition to a threshold value of
coronary atherectomy, rotational atherectomy, rheolytic          creatine kinase (CK) elevation has been commonly used.
thrombectomy catheter, proximal and distal embolic protec-       Most agree that the definition of MI as put forth by the
tion devices, excimer laser coronary atherectomy, and local      ACC/European Society of Cardiology document on the rede-
radiation devices to reduce in-stent restenosis (ISR) (16,17).   finition of MI (21) should be the accepted standard.
A variety of devices are under investigation, including new      However, the clinical significance and definition of cardiac
designs of balloon or self-expanding stents and mechanical       biomarker elevations in the absence of Q waves remains the
thrombectomy devices. This guideline update will focus on        subject of investigation and debate (21a). Several reports
the FDA-approved balloon-related and non-balloon coronary        have identified non–Q-wave MIs with CK-MB elevations 3
revascularization devices.
                                                                 to 5 times the upper limit of normal as having clinical sig-
                                                                 nificance (22,23). One report suggests that a greater than 5
3. OUTCOMES
                                                                 times increase in CK-MB is associated with worsened out-
The outcomes of PCI are measured in terms of success and         come (24). Thus, this degree of increase in CK-MB without
complications and are related to the mechanisms of the           Q waves is considered by most to qualify as an associated
employed devices, as well as the clinical and anatomic           complication of PCI. Troponin T or I elevation occurs fre-
patient-related factors. Complications can be divided into 2     quently after PCI. The timing of the peak elevation after PCI
categories: (a) those common to all arterial catheterization     is unclear (25). Minor elevations do not appear to have prog-
procedures and (b) those related to the specific technology      nostic value, whereas marked (greater than 5 times) eleva-
used for the coronary procedure. Specific definitions of suc-    tions are associated with worsened 1-year outcome (Table 2)
cess and complications exist, and where appropriate, the def-    (26-40). Troponin T or I elevation occurs more frequently
initions used herein are consistent with the ACC-National        than CK-MB increase after PCI (34).
Cardiovascular Data Registry (NCDR®) Catheterization
Laboratory Module version 3.0 (18). The committee recom-         3.1.3. Clinical Success
mends such standards whenever feasible in order to accom-
modate the common database for the assessment of out-            In the short term, a clinically successful PCI includes
comes. With increased operator experience, new technology,       anatomic and procedural success with relief of signs and/or
and adjunctive pharmacotherapy, the overall success and          symptoms of myocardial ischemia after the patient recovers
complication rates of angioplasty have improved.                 from the procedure. The long-term clinical success requires
                                                                 that the short-term clinical success remain durable and that
3.1. Definitions of PCI Success                                  the patient have persistent relief of signs and symptoms of
The success of a PCI procedure may be defined by angio-          myocardial ischemia for more than 6 months after the proce-
graphic, procedural, and clinical criteria.                      dure. Restenosis is the principal cause of lack of long-term
                                                                 clinical success when a short-term clinical success has been
3.1.1. Angiographic Success                                      achieved. Restenosis is not considered a complication but
                                                                 rather an associated response to vascular injury. The inci-
A successful PCI produces substantial enlargement of the         dence of clinically important restenosis may be judged by the
lumen at the target site. The consensus definition before the    frequency with which subsequent revascularization proce-
widespread use of stents was the achievement of a minimum
                                                                 dures are performed on target vessels after the index proce-
stenosis diameter reduction to less than 50% in the presence
                                                                 dure.
of grade 3 Thrombolysis In Myocardial Infarction (TIMI)
flow (assessed by angiography) (1). However, with the
advent of advanced adjunct technology, including coronary        3.2. Acute Outcome: Procedural Complications
stents, a minimum stenosis diameter reduction to less than       Class I
20% has been the clinical benchmark of an optimal angio-            All patients who have signs or symptoms suggestive of
graphic result. Frequently, there is a disparity between the        MI during or after PCI and those with complicated
visual assessment and computer-aided quantitative stenosis          procedures should have CK-MB and troponin I or T
measurement (19,20), and, thus, the determination of success        measured after the procedure. (Level of Evidence: B)
may be problematic when success rates are self-reported.
                                                                 Class IIa
3.1.2. Procedural Success                                           Routine measurement of cardiac biomarkers (CK-
A successful PCI should achieve angiographic success with-          MB and/or troponin I or T) in all patients undergoing
out major clinical complications (e.g., death, MI, emergency        PCI is reasonable 8 to 12 hours after the procedure.
coronary artery bypass surgery) during hospitalization (1,3).       (Level of Evidence: C)
Table 2. Incidence of Troponin Elevations After Percutaneous Coronary Intervention in the Published Literature

First Author of                                                                                   %                          Positive                                            Prognostic
Study (Reference)                        n                           Marker                     Positive                    Definition                                          Information                                               8
Hunt (29)                                22                       Troponin I                        0                      Greater than                                             N/A
                                                                                                                           6 ng per mL

Ravkilde (30)                            23                       Troponin T                       13                     Greater than                                              N/A
                                                                                                                         0.12 ng per mL

Karim (31)                               25                       Troponin T                       44                      Greater than                                             N/A
                                                                                                                          0.2 ng per mL
                                                                                                                                                                                                                                          Smith et al. 2005




La Vecchia (32)                    19 (Stent)                     Troponin T                    37 cTnI;                        N/A                                                 N/A
                                25 (balloon PCI)                     and                        21 cTnT
                                                                  troponin I                    14 cTnI;
                                                                                                 0 cTnT

Johansen (33)                            75                       Troponin T                       28                      Greater than                                             N/A
                                                                                                                          0.1 ng per mL
                                                                                                                                                                                                                                          ACC/AHA/SCAI Practice Guidelines




Shyu (34)                          59 (Stent)                     Troponin T                       29                      Greater than                        Significantly higher incidence of elevated cTnT in patients
                                61 (balloon PCI)                                                   13                     0.1 ng per mL                        undergoing stenting than angioplasty alone.


Bertinchant (35)                        105                       Troponin I                       22                      Greater than                        No difference in incidence of recurrent angina, MI, cardiac death,
                                                                                                                          0.1 ng per mL                        or RR after 12 months between patients positive or negative
                                                                                                                                                               for cTnI. Stenting not associated with more minor
                                                                                                                                                               myocardial damage than angioplasty.

Garbarz (36)                            109                       Troponin I                       27                      Greater than                        No association between post-PCI cTnI and adverse ischemic events.
                                                                                                                          0.3 ng per mL

Fuchs (37)                             1129                       Troponin I                       31                     Greater than                         cTnT levels greater than 3× normal limit associated
                                                                                                                         0.15 ng per mL                        with increased risk of major in-hospital complications,
                                                                                                                                                               but no association with adverse intermediate-term (8 months) clinical
                                                                                                                                                               outcomes.

Cantor (26)                             481                       Troponin I                  48 overall;                  Greater than                        Significantly higher 90-day rates of MI and the composite of MI
                                                                                                26 after                  1.5 ng per mL                        or death in patients with positive cTnI.
                                                                                               excluding
                                                                                              positive or
                                                                                               unknown
                                                                                             pre-PCI cTnI

Wu (38)                                  98                       Troponin T                       26                      Greater than                        At a mean of 77 months follow-up, no increase in risk of major adverse
                                                                                                                          0.1 ng per mL                        events detected in relation to post-PCI cTnT elevation.

Kizer (27)                              212                       Troponin T               40 positive prior              Greater than or                      Pre-PCI cTnT elevation was significantly related to event-free survival
                                                                                              to PCI; 18                     equal to                          during 6-year follow-up; in baseline negative patients, positive cTnT
                                                                                              of baseline                 0.1 ng per mL                        was the only independent predictor of major adverse events at 1 year;
                                                                                               negative                                                        post-PCI elevations of cTnT greater than or equal to 5× normal was the
                                                                                            were positive                                                      strongest long-term predictor of major adverse events at 6 years.
                                                                                               post-PCI


Ricciardi (39)                          286                       Troponin I                      13.6                     Greater than                        cTnI elevations greater than 3-fold care predictive of future major
                                                                                                                          2.3 ng per mL                        adverse cardiac events (MACE). Increased incidence of MACE
                                                                                                                                                               is accounted for by higher rate of early RR and not late cardiac events.

Kini (40)                              2873                       Troponin I                      38.9                     Greater than                        Neither cTnI peak elevations nor any subgroup predicted mid-term
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                                                                                                                           2 ng per mL                         mortality in low- to medium-risk patients.
cTnI indicates cardiac troponin I; cTnT, cardiac troponin T; N/A, not applicable; PCI, percutaneous coronary intervention; and RR, repeat revascularization.
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AHA - www.americanheart.org                                                                             Smith et al. 2005
SCAI - www.scai.org                                                                     ACC/AHA/SCAI Practice Guidelines        9

  Complications associated with PCI are similar to those             Another study indicated that more extensive stent expan-
resulting from diagnostic cardiac catheterization, but their       sion resulted in CK release but did not increase adverse car-
prevalence is more frequent. Complications have been cate-         diac events (59). Accordingly, it is important to acknowledge
gorized as major (death, MI, and stroke) or minor (transient       that the significance of mild biomarker rises after clinically
ischemic attack, access site complications, renal insufficien-     successful PCI should be distinguished from situations
cy, or adverse reactions to radiographic contrast). Additional     wherein patients experience an unequivocal “clinical” infarc-
specific complications include intracoronary thrombosis,           tion manifested by chest pain and diagnostic ECG findings
coronary perforation, tamponade, and arrhythmias.                  (60).
  Reported rates for death after diagnostic catheterization          Routine measurement of CK-MB is advocated by some
range from 0.08% to 0.14%, whereas analyses of large reg-          (21) and actually mandated by certain healthcare systems. In
istries indicate overall unadjusted in-hospital rates for PCI of   this regard, the current Committee supports the recommen-
0.4% to 1.9% (Table 3) (41-52). This range is greatly influ-       dations of the 2001 Guidelines and recommends that all
enced by the clinical indication for which PCI is performed,       patients who have signs or symptoms suggestive of MI dur-
with the highest mortality rates occurring among patients          ing or after PCI and those with complicated procedures
with STEMI and cardiogenic shock. Death in such patients           should have CK-MB and troponin I or T measured after the
may not be a direct result of the PCI procedure but rather a       procedure. In addition, the Committee recommends that rou-
consequence of the patient’s underlying illness. For example,      tine measurement of cardiac biomarkers (CK-MB and/or tro-
in a combined analysis of PCI as primary reperfusion thera-        ponin I or T) in every patient undergoing PCI is reasonable 8
py for STEMI, the short-term mortality rate was 7% (53).           to 12 h after the procedure. In such patients, a new CK-MB
Even after exclusion of patients with cardiogenic shock, in-       or troponin I or T rise greater than 5 times the upper limit of
hospital mortality was 5%.                                         normal would constitute a clinically significant periproce-
  Myocardial infarction can be a direct result of PCI, most        dural MI.
commonly due to abrupt coronary occlusion or intracoronary           The need to perform emergency coronary artery bypass
embolization of obstructive debris. Determining and com-           surgery (CABG) has been considered as a potential compli-
paring the incidence of MI after PCI is difficult because the      cation of PCI. Typically, CABG is performed as a rescue
definition of MI as a result of PCI is controversial. The con-
                                                                   revascularization procedure to treat acute ischemia or infarc-
ventional definition requires 2 of the following: a) prolonged
                                                                   tion resulting from PCI-induced acute coronary occlusion. In
chest discomfort or its equivalent; b) development of patho-
                                                                   the era of balloon angioplasty, the rate of emergency CABG
logic Q waves; and c) rise in serum cardiac biomarkers above
                                                                   was 3.7% (49). In a more contemporary time period, with the
a critical level. Rates of periprocedural MI using this defini-
                                                                   availability of stents, the reported rate was 0.4% among a
tion have ranged from 0.4% to 4.9%. Using a consistent def-
                                                                   similar cohort of patients.
inition for MI, the incidence of this complication has
declined approximately 50% with the routine use of intra-            Various definitions have been proposed for stroke. A com-
coronary stents (21,21a,50).                                       mon feature to definitions has been a loss of neurologic func-
  More recently, an isolated rise and fall in either CK-MB or      tion of vascular cause that lasts more than 24 h. More recent-
troponin is considered to be a marker of myocardial necrosis       ly, attention has been directed to refining the definition of
(21). The relationship between cardiac biomarker elevation         transient ischemic attack (TIA), which indirectly broadens
and myocardial cell death and evidence of subendocardial           that of stroke (61). The time-based definition of a TIA is a
infarction on magnetic resonance imaging (MRI) support             sudden, focal neurologic deficit that lasts less than 24 h that
this position (54,55). Furthermore, large rises in cardiac bio-    is of presumed vascular origin and confined to an area of the
markers are associated with an increased risk for late death       brain or eye perfused by a specific artery. The new definition
(26,56,57). Whether death in such patients is a consequence        of TIA is a brief episode of neurologic dysfunction caused by
of the myonecrosis or a marker of patients who are at              brain or retinal ischemia, with clinical symptoms typically
increased risk for death because of more advanced coronary         lasting less than 1 hour and without evidence of infarction.
disease is unclear. Complicating our understanding of the          Presence of cerebral infarction by imaging techniques con-
implications of this definition is the very frequently observed    stitutes evidence of stroke regardless of the duration of
mild to modest elevation of serum CK-MB among patients             symptoms.
with apparently uncomplicated PCI. When troponin is meas-            Bleeding is a complication of increasing concern with the
ured after PCI, more than 70% of patients exhibit elevated         more frequent use of potent antithrombin and antiplatelet
values after an otherwise successful intervention (58). Such       agents. A frequently used definition for bleeding developed
patients may have no symptoms or electrocardiographic              by the TIMI group includes classification as major, moder-
(ECG) abnormalities to suggest ischemia yet are “enzyme            ate, or minor. Major bleeding is defined as intracranial,
positive.” One study has suggested a postprocedural increase       intraocular, or retroperitoneal hemorrhage or any hemor-
in troponin T of 5 times normal is predictive for adverse          rhage requiring a transfusion or surgical intervention or that
events at 6 years. The long-term prognostic significance of        results in a hematocrit decrease of greater than 15% or hemo-
smaller postprocedural troponin T elevations awaits further        globin decrease of greater than 5 g per dL (62). Episodes of
investigation (27) (Table 2) (26-40).                              hemorrhage of lesser magnitude would fall into the moder-
10
                                                                                                                                                                                                                                 Smith et al. 2005




Table 3. Unadjusted In-Hospital Outcome Trends After Percutaneous Coronary Interventions
                                                                                                                           Clinical Success,           In-Hospital                  Q-Wave                  Emergency
Registry                                       Years                    Reference                         n                       %                    Mortality, %                 MI, %                   CABG, %
NHLBI (I)‡                                  1977-1981                        (41)                       3079*                       61                       1.2                       NR                         5.8
                                                                                                                                                                                                                                 ACC/AHA/SCAI Practice Guidelines




NHLBI (II)§                                 1985-1986                        (41)                       2311*                       78                       1.0                       4.8                        5.8
BARI Registry||                             1988-1991                        (42)                       1189*                      NR                        0.7                       2.8                        4.1
Northern New England¶                       1990-1993                        (43)                      13 014†                     88.8                      1.0                       2.4                        2.2
SCAI#                                       1990-1994                        (44)                       4366†                      91.5                      2.5                       NR                         3.4
NACI**                                      1990-1994                        (45)                       4079*                      NR                        1.6                       1.6                        1.9
NY State Database                           1991-1994                      (46,47)                     62 670*                     NR                         0.9                      NR                         3.4
Northern New England¶                       1994-1995                        (43)                       7248†                      89.2                      1.1                       2.1                        2.3
NCN                                         1994-1997                        (48)                      76 904†                     NR                        1.3                       NR                         1.7
Northern New England¶                       1995-1997                        (43)                      14 490†                     91.5                      1.2                       2.0                        1.3
NHLBI Dynamic Registry‡‡                    1997-1998                        (49)                       1559*                       92                       1.9                       2.8                        0.4
NHLBI Dynamic                               1997-1999                        (50)                        857                        91                       0.9                       0.8                        1.9
ACC-NCDR                                    1998-2000                        (51)                      100 292                     96.5                      1.4                       0.4                        1.9
NY State Database                           1997-2000                        (52)                       22 102                     NR                        0.68                      NR                         NR
CABG indicates coronary artery bypass graft surgery; MI, myocardial infarction; NACI, New Approaches in Coronary Interventions; NCN, National Cardiovascular Network; and NR, not reported.
*N indicates number of patients.
†N indicates number of procedures.
‡In NHLBI (I), emergency CABG was defined as in-hospital CABG.
§In NHLBI (II), MI was defined as the presence of at least 2 of the 3 criteria: clinical symptoms, Q waves on ECG (Minnesota code), or elevated cardiac enzyme level (double the normal levels for CK or its MB fraction
without Q waves). Emergency CABG was defined as in-hospital CABG.
||In BARI, MI was defined as the appearance of ECG changes (new pathologic Q waves) supported by abnormal CK-MB elevations.
¶In Northern New England, a new MI was defined as a clinical event, ECG changes, and a creatinine phosphokinase rise at least 2 times normal levels with positive isozymes. Emergency CABG was defined as surgery per-
    formed to treat acute closure, unstable angina, or congestive heart failure requiring intravenous nitroglycerin or ABP, or tamponade resulting from the intervention.
#In SCAI, a new MI was defined as any significant infarction (greater than 3 times normal rise in MB fraction).
**In NACI, MI was defined as a Q-wave MI.
††MI was defined as 2 or more of the following: 1) typical chest pain greater than 20 min not relieved by nitroglycerin; 2) serial ECG recordings showing changes from baseline or serially in ST-T and/or Q waves in at least
    2 contiguous leads; or 3) serum enzyme elevation of CK-MB greater than 5% of total CK (total CK more than 2 times normal; lactate dehydrogenase subtype 1 greater than lactate dehydrogenase subtype 2).
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AHA - www.americanheart.org                                                                              Smith et al. 2005
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ate/minor categories. A listing of other bleeding classifica-        In addition to multivessel disease, other clinical factors
tions has been developed for use by the ACC-NCDR® (18).            adversely impact late mortality. In randomized patients with
                                                                   treated diabetes undergoing PTCA in BARI, the 5-year sur-
3.3. Acute Outcome: Success Rates                                  vival was 65.5%, and the cardiac mortality rate was 20.6%
                                                                   compared with 5.8% in patients without treated diabetes
Success has been described on both a lesion and patient            (67), although among eligible but not randomized diabetic
basis. In early studies of PTCA, lesion success is defined as      patients treated with PTCA, the 5-year cardiac mortality rate
an absolute 20% reduction in lesion severity with final steno-     was 7.5% (68). In the 1985-1986 NHLBI PTCA Registry, 4-
sis less than 50%. When describing the results of multiple         year survival was significantly lower in women (89.2%) than
attempted lesions, success is classified as either partial (some   in men (93.4%) (69). In addition, although LV dysfunction
but not all attempted lesions successfully treated) or total       was not associated with an increase in in-hospital mortality
(each attempted lesion successfully treated). Procedural suc-      or nonfatal MI in patients undergoing PTCA in the same reg-
cess is defined as the achievement of either partial or total      istry, it was an independent predictor of a higher long-term
angiographic success without death, MI, or emergency               mortality (70).
CABG (49).                                                           A major determinant of event-free survival after coronary
  Reported rates of angiographic success now range between         intervention is the incidence of restenosis, which had, until
82% and 98% depending on the device used and the types of          the development of stents, remained fairly constant despite
lesions attempted. Formal comparisons demonstrate that suc-        multiple pharmacologic and mechanical approaches to limit
cess rates are now higher (91% to 92%) in the era of new           this process (Table 4) (71-95). The incidence of restenosis
technology, which includes stents and contemporary drug            after coronary intervention varies depending on the defini-
therapies, than in the era of conventional balloon angioplas-      tion, i.e., whether clinical or angiographic restenosis or tar-
ty (72% to 74%) (49). The types of lesions attempted strong-       get-vessel revascularization is measured (96). Data from
ly influence success rates. The chance of dilating a chronic       multiple randomized clinical trials and prospective registries
total occlusion averages 65%, and specific clinical and            suggest that DES incorporating either rapamycin or paclitax-
anatomic factors have been identified that affect this rate        el with a timed-release polymer are associated with a reduc-
(63). Quite different are the success rates for total occlusions   tion in restenosis rates to less than 10% across a wide spec-
associated with STEMI. Success rates over 90% can be               trum of clinical and angiographic subsets.
expected in this subgroup (64).                                      The pathogenesis of the response to mechanical coronary
  With an increase in angiographic success rates and a             injury is thought to relate to a combination of growth factor
decline in periprocedural MI and the need for emergency            stimulation, smooth muscle cell migration and proliferation,
CABG, procedural success rates have risen from a range of          organization of thrombus, platelet deposition, and elastic
80% to 85% to a range of 90% to 95% (Table 3) (41-52).             recoil (97,98). In addition, change in vessel size (or lack of
                                                                   compensatory enlargement) has been implicated (99). It has
3.4. Long-Term Outcome and Restenosis                              been suggested that attempts to reduce restenosis have failed
                                                                   in part because of lack of recognition of the importance of
Although improvements in technology, such as stents, have          this factor (100). Although numerous definitions of resteno-
resulted in an improved acute outcome of the procedure, the        sis have been proposed, greater than 50% diameter stenosis
impact of these changes on long-term (5 to 10 years) out-          at follow-up angiography has been most frequently used
come may be less dramatic because factors such as advanced         because it was thought to correlate best with maximal flow
age, reduced left ventricular (LV) function, and progression       and therefore ischemia. However, it is now recognized that
of complex multivessel disease in patients currently under-        the response to arterial injury is a continuous rather than a
going PCI may have a more important influence. In addition,        dichotomous process, occurring to some degree in all
available data on long-term outcome are mostly limited to          patients (101). Therefore, cumulative frequency distributions
patients undergoing PTCA. Ten-year follow-up of the initial        of the continuous variables of minimal lumen diameter or
cohort of patients treated with PTCA revealed an 89.5% sur-        percent diameter stenosis are frequently used to evaluate
vival rate (95% in patients with single-vessel disease, 81% in     restenosis in large patient populations (102) (Figure 2) (80).
patients with multivessel disease) (65). In patients undergo-        Although multiple clinical factors (diabetes, unstable angi-
ing PTCA within the 1985-1986 National Heart, Lung, and            na [UA]/NSTEMI, STEMI, and prior restenosis) (103,104),
Blood Institute (NHLBI) PTCA Registry (66), 5-year sur-            angiographic factors (proximal left anterior descending
vival was 92.9% for patients with single-vessel disease,           artery [LAD], small vessel diameters, total occlusion, long
88.5% for those with 2-vessel disease, and 86.5% for those         lesion length, and saphenous vein grafts [SVGs]) (105), and
with 3-vessel disease. In patients with multivessel disease        procedural factors (higher postprocedure percent diameter
undergoing PTCA in the Bypass Angioplasty                          stenosis, smaller minimal lumen diameter, and smaller acute
Revascularization Investigation (BARI) (10), 5-year survival       gain) (102) have been associated with an increased incidence
was 86.3%, and infarct-free survival was 78.7%.                    of restenosis, the ability to integrate these factors and predict
Specifically, 5-year survival was 84.7% in patients with 3-        the risk of restenosis in individual patients after the proce-
vessel disease and 87.6% in patients with 2-vessel disease.        dure remains difficult. The most promising potential
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12        ACC/AHA/SCAI Practice Guidelines                                                                                                       SCAI - www.scai.org

 Table 4. Selected Trials of Pharmacological and Mechanical Approaches to Limit Restenosis

                                                                                                                                       Restenosis Rate, %
 Study                      Year               Reference                    n                            Agent                      Placebo or Control Agent
 Schwartz                   1988                   (71)                   376               Aspirin and dipyridamole                      39             38
 Ellis                      1989                   (72)                   416                        Heparin                              37             41
 Pepine                     1990                   (73)                   915                  Methylprednisolone                         39             40
 CARPORT                    1991                   (74)                   649                       Vapiprost                             19             21
 O’Keefe                    1992                   (75)                   197                      Colchicine                             22             22
 MERCATOR                   1992                   (76)                   735                       Cilazapril                            28             28
 CAVEAT*                    1993                   (77)                   500                  DCA versus PTCA                            57             50
 CCAT                       1993                   (78)                   136                  DCA versus PTCA                            43             46
 Serruys                    1993                   (79)                   658                      Ketanserin                             32             32
 BENESTENT*                 1994                   (80)                   520                  Stent versus PTCA                          32             22
 ERA                        1994                   (81)                   458                      Enoxaparin                             51             52
 Leaf                       1994                   (82)                   551                         Fish oil                            46             52
 STRESS*                    1994                   (83)                   410                  Stent versus PTCA                          42             32
 Weintraub                  1994                   (84)                   404                       Lovastatin                            42             39
 BOAT*                      1998                   (85)                   492                  DCA versus PTCA                            40             31
 Wantanabe*                 1996                   (86)                   118                        Probucol                             40             20
 Tardif*                    1997                   (87)                   317                        Probucol                             39             21
 BENESTENT II*              1998                   (88)                   823                  Stent versus PTCA                          31             17
 TREAT*                     1999                   (89)                   255                        Tranilast                            39             18
 PRESTO*                    2000                   (90)                   192                   DCA and Tranilast                         26             11
 ARTIST*                    2002                   (91)                   298                 Rotablation (in-stent)                      51             65
                                                                                                  versus PTCA
 START*                     2002                   (92)                   476                  Radiation (in-stent)                       45             29
 SIRIUS*                    2003                   (93)                  1058             Sirolimus-coated stent versus                   36             9
                                                                                                    bare stent
 TAXUS-IV*                  2004                   (94)                  1314             Paclitaxel-coated stent versus                  27             8
                                                                                                    bare stent
 RESCUT                     2004                   (95)                   428               Cutting balloon (in-stent)                    31             30
                                                                                                  versus PTCA

 DCA indicates directional coronary atherectomy; n, number of patients; and PTCA, percutaneous transluminal coronary angioplasty.

 *P less than 0.05.


approaches to favorably impact the restenosis process are                                    clopidogrel. The development of DES has significantly
stents and, more recently, DES and catheter-based radiation.                                 reduced the rate of ISR (see Section 7.3.6 for full discus-
More than 6300 patients have been studied in 12 randomized                                   sion).
clinical trials to assess the efficacy of PTCA versus stents to
reduce restenosis (Table 5) (80,83,88,106-114).                                              3.5. Predictors of Success/Complications
  The pivotal BENESTENT (BElgian NEtherlands STENT
                                                                                             3.5.1. Lesion Morphology and Classification
study) (80) and STRESS (STent REStenosis Study) trials
(83) documented that stents significantly reduce angiograph-                                 Target lesion anatomic factors related to adverse outcomes
ic restenosis compared with balloon angioplasty (BENES-                                      have been widely examined. Lesion morphology and
TENT: 22% vs 32%; STRESS: 32% vs 42%, respectively).                                         absolute stenosis severity were identified as the prominent
These results were further corroborated in the BENESTENT                                     predictors of immediate outcome during PTCA in the
II trial, in which the angiographic restenosis rate was reduced                              prestent era (118,119). Abrupt vessel closure, due primarily
by almost half (from 31% to 16% in patients treated with bal-                                to thrombus or dissection, was reported in 3% to 8% of
loon angioplasty versus heparin-coated stents, respectively)                                 patients and was associated with certain lesion characteris-
(88).                                                                                        tics (120-122). The risk of PTCA in the prestent era relative
  In addition, randomized studies in patients with ISR have                                  to anatomic subsets has been identified in previous NHLBI
shown that both intracoronary gamma and beta radiation sig-                                  PTCA Registry data (7) and by the ACC/AHA Task Force on
nificantly reduced the rate of subsequent angiographic and                                   Practice Guidelines (1,123). The lesion classification based
clinical restenosis by 30% to 50% (92,115-117). Late suba-                                   on severity of characteristics proposed in the past (123-125)
cute thrombosis was observed in some of these series (117),                                  has been principally altered using the present PCI tech-
but this syndrome has resolved with judicious use of stents                                  niques, which capitalize on the ability of stents to manage
and extended adjunct antiplatelet therapy with ticlopidine or                                initial and subsequent complications of coronary interven-
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AHA - www.americanheart.org                                                                                  Smith et al. 2005
SCAI - www.scai.org                                                                          ACC/AHA/SCAI Practice Guidelines        13




Figure 2. Balloon stent vs balloon angioplasty in coronary artery disease. Cumulative frequency distribution curves for the 2 study
groups, showing minimum lumen diameters measured before and after intervention and follow-up (B), the percentage of stenosis at
follow-up, and the percentage of patients with clinical end points. Significant differences were apparent that consistently favored the
stent group over the angioplasty group with respect to the increased minimal lumen diameter at intervention (A) and follow-up (B),
the percentage of stenosis at follow-up (C), and the incidence of major clinical events (D). The vertical dashed line in D indicated the
end of the study. Reprinted with permission from Serruys et al. N Engl J Med 1994;331:489-95 (80). Copyright 2004 Massachusetts
Medical Society. All rights reserved.

tions (126). As a result, the Committee has revised the previ-        the operator classified the lesion after finishing the case and
ous ACC/AHA lesion classification system to reflect high-             knowing whether the case was successful or had complica-
risk (at least 1 type C lesion characteristic) and non–high-          tions. No prospective studies using core laboratory analysis
risk (no type C lesion characteristic) lesions (Table 6) in           have validated this system. Nonetheless, the SCAI classifi-
accordance with the PCI Clinical Data Standards from the              cation system utilizing vessel patency in addition to C and
ACC-NCDR® (18). Studies (127-130) have confirmed that                 non-C class appears promising to categorize the risk of suc-
complex coronary lesions remain predictive of adverse                 cess and complications with PCI.
events after PCI. However, although the risk of restenosis
and technical failure remains high for chronic total occlu-           3.5.1.1. Clinical Factors
sions, the risk of acute complications is not increased.              Coexistent clinical conditions can increase the complication
  The SCAI proposed a new lesion classification using 7               rates for any given anatomic risk factor. For example, com-
lesion characteristics (131). This system dichotomizes                plications occurred in 15.4% of patients with diabetes versus
lesions by the presence or absence of a type C characteristic         5.8% of patients without diabetes undergoing balloon angio-
and vessel patency versus total occlusion, yielding 4 lesion          plasty in a multicenter experience (119,122). Several studies
classes (Table 7) (132). Utilizing data from the voluntary            have reported specific factors associated with increased risk
ACC-NCDR®, the SCAI group presented analyses that                     of adverse outcome after PTCA. These factors include
showed that the more simplified SCAI lesion classification            advanced age, female gender, UA, congestive heart failure
provided better discrimination for success and complications          (CHF), diabetes, and multivessel CAD (10,118,119,127-
than the ACC/AHA lesion classification system (132,133).              130,134,135). Elevated baseline C-reactive protein (CRP)
  The SCAI lesion classification system was validated from            has recently also been shown to be predictive of 30-day death
a voluntary registry, which imposes a potential bias because          and MI (128,136). Other markers of inflammation, such as
14
                                                                                                                                                                                                                               Smith et al. 2005




Table 5. Studies Comparing Balloon Angioplasty with Stents for Native Coronary Artery Lesions
                             Follow-Up, n, Stent/       Angiographic Restenosis, %                TVR, %                                                                                       Death, %
Study (Ref)             Year      mo    Angioplasty Stent Angioplasty P value               Stent Angioplasty P value                                                           Stent       Angioplasty P value
                                                                                                                                                                                                                               ACC/AHA/SCAI Practice Guidelines




STRESS (83)                      1994            6          205/202            31.6          42.1            0.046             10.2          15.4            0.06               1.5               1.5              NS
BENESTENT (80,107) 1996                       7/12*         259/257             22            32             0.02               10             21           0.001               1.2               0.8              NS
Versaci et al. (108)             1997           12            60/60             19            40             0.02              6.6             22             NA                NA                NA              NA
STRESS II (109)                  1998           12           100/89            NA            NA               NA                10             20             NA                17||              34||            NA
BENESTENT II (88)                1998            6          413/410             16            31          Less than             8†           13.7            0.02               0.2%             0.5%              NS
                                                                                                           0.001
OCBAS (110)                      1998            7            57/59            18.8          16.6             NA               17.5           9.2             NA                0                 1.6              NS
EPISTENT (111,112)‡              1998            6          794/796            NA            NA               NA               8.7           15.4         Less than             0.5               1.8             0.02
                                                                                                                                                           0.001
START (113)                      1999         6/48§         229/223             22            37          Less than             12           24.6         Less than             2.7               2.4              NS
                                                                                                           0.002                                           0.002
OPUS (114)                       2000            6       479 (Overall)         NA            NA               NA               3.0           10.1           0.003               0.4               1.2              NS
mo indicates months; NA, data not reported for that category, NS, not significant; and TVR, target vessel revascularization. Data are for lesions in coronary arteries with vessel diameter greater than or equal to 3.0 mm.
*6-7 months angiographic follow-up and 12 months clinical follow-up.
†Any repeat procedure.
‡Stent plus abciximab versus percutaneous transluminal angioplasty plus abciximab.
§6 months angiographic follow-up and 48 months clinical follow-up.
||End point of death/any MI/CABG/target lesion percutaneous transluminal angioplasty.
Modified with permission from AI SJ et al. JAMA 2000;284:1828-36 (106).
                                                                                                                                                                                                                                       SCAI - www.scai.org
                                                                                                                                                                                                                               AHA - www.americanheart.org
                                                                                                                                                                                                                                        ACC - www.acc.org
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))
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ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention (eng))

  • 1. © 2005 by the American College of Cardiology Foundation and the American Heart Association, Inc. ACC/AHA/SCAI PRACTICE GUIDELINES—FULL TEXT (Track Change Version)* ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) WRITING COMMITTEE MEMBERS Sidney C. Smith, Jr, MD, FACC, FAHA, Chair Ted E. Feldman, MD, FACC, FSCAI† Douglass A. Morrison, MD, PhD, FACC, FSCAI† John W. Hirshfeld, Jr, MD, FACC, FSCAI† William W. O’Neill, MD, FACC, FSCAI Alice K. Jacobs, MD, FACC, FAHA, FSCAI Hartzell V. Schaff, MD, FACC, FAHA Morton J. Kern, MD, FACC, FAHA, FSCAI† Patrick L. Whitlow, MD, FACC, FAHA Spencer B. King, III, MD, MACC, FSCAI David O. Williams, MD, FACC, FAHA, FSCAI TASK FORCE MEMBERS Elliott M. Antman, MD, FACC, FAHA, Chair Sidney C. Smith, Jr., MD, FACC, FAHA, Vice Chair Cynthia D. Adams, MSN, APRN-BC, FAHA Sharon Ann Hunt, MD, FACC, FAHA Jeffrey L. Anderson, MD, FACC, FAHA Alice K. Jacobs, MD, FACC, FAHA David P. Faxon, MD, FACC, FAHA‡ Rick Nishimura, MD, FACC, FAHA Valentin Fuster, MD, PhD, FACC, FAHA, FESC‡ Joseph P. Ornato, MD, FACC, FAHA Jonathan L. Halperin, MD, FACC, FAHA Richard L. Page, MD, FACC, FAHA Loren F. Hiratzka, MD, FACC, FAHA‡ Barbara Riegel, DNSc, RN, FAHA *Changes in the recommendations from the 2001 guidelines to the 2005 guide- Guidelines for Percutaneous Coronary Intervention). American College of line update are reflected by strike-through showing deleted text and under- Cardiology Web Site. Available at: http://www.acc.org/clinical/guidelines/per- lining showing new text. cutaneous/update/index_rev.pdf. †SCAI Official Representative ‡Former Task Force Member during this writing effort Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org), the American Heart Acknowledgement: The ACC and AHA recognize Dr J. Ward Kennedy for his Association (www.americanheart.org), and the Society for Cardiovascular dedicated service on developing ACC/AHA guidelines for PTCA and PCI since Angiography and Interventions (www.scai.org). Single copies of this document their inception in 1986 and for his counsel and advice in the preparation of this are available by calling 1-800-253-4636 or writing the American College of guideline. Cardiology Foundation, Resource Center, at 9111 Old Georgetown Road, Bethesda, MD 20814-1699. Ask for reprint number 71-0347. To obtain a copy This document was approved by the American College of Cardiology of the Summary Article published in the January 3, 2006 issue of the Journal Foundation Board of Trustees in August 2005, by the American Heart of the American College of Cardiology, the January 3, 2006 issue of Association Science Advisory and Coordinating Committee in August 2005, Circulation, and the January 2006 issue of Catheterization and Cardiovascular and by the Society for Cardiovascular Angiography and Interventions Board of Interventions, ask for reprint number 71-0346. To purchase bulk reprints (spec- Trustees in August 2005. ify version and reprint number): Up to 999 copies, call 1-800-611-6083 US When citing this document, the American College of Cardiology Foundation only) or fax 413-665-2671; 1000 or more copies, call 214-706-1789, fax 214- requests that the following citation format be used: Smith SC Jr, Feldman TE, 691-6342, or e-mail pubauth@heart.org. Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB III, Morrison DA, O’Neill WW, Schaff HV, Whitlow PL, Williams DO. ACC/AHA/SCAI 2005 guideline Permissions: Multiple copies, modification, alteration, enhancement, and/or update for percutaneous coronary intervention: a report of the American distribution of this document are not permitted without the express permission College of Cardiology/American Heart Association Task Force on Practice of the American College of Cardiology Foundation. Please direct requests to Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 copyright_permissions@acc.org.
  • 2. ACC - www.acc.org Smith et al. 2005 AHA - www.americanheart.org 2 ACC/AHA/SCAI Practice Guidelines SCAI - www.scai.org TABLE OF CONTENTS 5.5.2. Late Ischemia After CABG................................ 57 5.5.3. Early and Late Outcomes of Percutaneous PREAMBLE.............................................................................. 3 Intervention........................................................ 58 1. INTRODUCTION................................................................. 3 5.5.4. General Considerations...................................... 58 5.6. Use of Adjunctive Technology (Intracoronary 2. GENERAL CONSIDERATIONS AND Ultrasound Imaging, Flow Velocity, and Pressure)......58 BACKGROUND................................................................... 6 5.6.1. Intravascular Ultrasound Imaging......................58 3. OUTCOMES......................................................................... 7 5.6.2. Coronary Artery Pressure and Flow: Use of 3.1. Definitions of PCI Success.............................................7 Fractional Flow Reserve and Coronary 3.1.1. Angiographic Success .......................................... 7 Vasodilatory Reserve..........................................60 3.1.2. Procedural Success...............................................7 3.1.3. Clinical Success................................................... 7 6. MANAGEMENT OF PATIENTS UNDERGOING PCI.... 61 3.2. Acute Outcome: Procedural Complications................... 7 6.1. Evolution of Technologies............................................61 3.3. Acute Outcome: Success Rates.................................... 11 6.1.1. Acute Results......................................................62 3.4. Long-Term Outcome and Restenosis........................... 11 6.1.2. Late-Term Results.............................................. 62 3.5. Predictors of Success/Complications .......................... 12 6.2. Antiplatelet and Antithrombotic Adjunctive 3.5.1. Lesion Morphology and Classification.............. 12 Therapies For PCI........................................................ 62 3.5.1.1. Clinical Factors..................................... 13 6.2.1. Oral Antiplatelet Therapy................................... 62 3.5.1.2. Left Main CAD..................................... 15 6.2.2. Glycoprotein IIb/IIIa Inhibitors......................... 66 3.5.2. Risk of Death..................................................... 18 6.2.2.1. Abciximab............................................. 67 3.5.3. Women................................................................18 6.2.2.2. Eptifibatide............................................ 69 3.5.4. The Elderly Patient.............................................20 6.2.2.3. Tirofiban................................................ 70 3.5.5. Diabetes Mellitus............................................... 20 6.2.3. Antithrombotic Therapy..................................... 70 3.5.6. PCI After Coronary Artery Bypass Surgery.......21 6.2.3.1. Unfractionated Heparin, Low-Molecular- 3.5.7. Specific Technical Considerations..................... 21 Weight Heparin, and Bivalirudin...........70 3.5.8. Issues of Hemodynamic Support in 6.2.3.2. Heparin Dosing Guidelines...................72 High-Risk PCI.................................................... 22 6.3. Post-PCI Management..................................................72 3.6. Comparison With Bypass Surgery................................22 6.3.1. Postprocedure Evaluation of Ischemia...............73 3.7. Comparison With Medicine......................................... 24 6.3.2. Risk Factor Modifications..................................74 4. INSTITUTIONAL AND OPERATOR COMPETENCY.... 29 6.3.3. Exercise Testing After PCI.................................74 4.1. Quality Assurance.........................................................29 6.3.4. Left Main CAD.................................................. 74 4.2. Operator and Institutional Volume............................... 31 7. SPECIAL CONSIDERATIONS.......................................... 78 4.3. Role of Onsite Cardiac Surgical Back-up.................. 35 7.1. Ad Hoc Angioplasty—PCI at the Time of Initial 4.4. Primary PCI for STEMI Without Onsite Cardiac Cardiac Catheterization................................................ 78 Surgery..........................................................................37 7.2. PCI in Cardiac Transplant Patients.............................. 79 4.5. Elective PCI Without Onsite Surgery...........................39 7.3. Clinical Restenosis: Background and Management.....79 5. CLINICAL PRESENTATIONS.......................................... 39 7.3.1. Background on Restenosis After PTCA............ 79 5.1. Patients With Asymptomatic Ischemia or CCS 7.3.2. Clinical and Angiographic Factors for Restenosis Class I or II Angina...................................................... 40 After PTCA........................................................ 79 5.2. Patients With CCS Class III Angina............................ 41 7.3.3. Management Strategies for Restenosis After 5.3. Patients With UA/NSTEMI..........................................42 PTCA..................................................................81 5.4. Patients With STEMI................................................... 43 7.3.4. Background on Restenosis After BMS 5.4.1. General and Specific Considerations................. 43 Implantation....................................................... 81 5.4.2. PCI in Fibrinolytic-Ineligible Patients............... 51 7.3.5. Drug-Eluting Stents............................................82 5.4.3. Facilitated PCI....................................................51 7.3.6. Management Strategies for ISR......................... 87 5.4.4. PCI After Failed Fibrinolysis (Rescue PCI)...... 51 7.3.6.1. PTCA.....................................................87 5.4.5. PCI After Successful Fibrinolysis or for 7.3.6.2. Drug-Eluting Stents...............................87 Patients Not Undergoing Primary Reperfusion. 53 7.3.6.3. Radiation............................................... 88 5.4.6. PCI for Cardiogenic Shock................................ 54 7.3.6.4. Medical Therapy....................................88 5.4.7. PCI in Selected Patient Subgroups.................... 55 7.3.7. Subacute Stent Thrombosis................................90 5.4.7.1. Young and Elderly Postinfarct Patients.55 7.3.8. Drug-Eluting Stents: Areas Requiring Further 5.4.7.2. Patients With Prior MI.......................... 56 Investigation....................................................... 90 5.5. Percutaneous Intervention in Patients With Prior 7.4. Cost-Effectiveness Analysis for PCI............................ 90 Coronary Bypass Surgery.............................................56 5.5.1. Early Ischemia After CABG...............................57 8. FUTURE DIRECTIONS..................................................... 91
  • 3. ACC - www.acc.org AHA - www.americanheart.org Smith et al. 2005 SCAI - www.scai.org ACC/AHA/SCAI Practice Guidelines 3 Appendix 1. Relationships With Industry: Writing nosis, management, or prevention of specific diseases or Committee............................................................92 conditions. These guidelines attempt to define practices that Appendix 2. Relationships With Industry: Peer meet the needs of most patients in most circumstances. These Reviewers............................................................ 93 guideline recommendations reflect a consensus of expert opinion after a thorough review of the available, current sci- References................................................................................94 entific evidence and are intended to improve patient care. If these guidelines are used as the basis for regulatory/payer decisions, the ultimate goal is quality of care and serving the PREAMBLE patient’s best interests. The ultimate judgment regarding care It is important that the medical profession play a significant of a particular patient must be made by the healthcare role in critically evaluating the use of diagnostic procedures provider and patient in light of all of the circumstances pre- and therapies as they are introduced and tested in the detec- sented by that patient. tion, management, or prevention of disease states. Rigorous These guidelines were approved for publication by the gov- and expert analysis of the available data documenting rela- erning bodies of the ACCF, AHA, and SCAI. The guidelines tive benefits and risks of those procedures and therapies can will be reviewed annually by the ACC/AHA Task Force on produce helpful guidelines that improve the effectiveness of Practice Guidelines and will be considered current unless care, optimize patient outcomes, and favorably affect the they are revised or withdrawn from distribution. The sum- overall cost of care by focusing resources on the most effec- mary article and recommendations are published in the tive strategies. January 3, 2006 issue of the Journal of the American College The American College of Cardiology (ACC) and the of Cardiology, the January 3, 2006 issue of Circulation, and American Heart Association (AHA) have jointly engaged in the January 2006 issue of Catheterization and Cardio- the production of such guidelines in the area of cardiovascu- vascular Interventions. The full-text guideline is posted on lar disease since 1980. This effort is directed by the the World Wide Web sites of the ACC (www.acc.org), the ACC/AHA Task Force on Practice Guidelines, whose charge AHA (www.americanheart.org), and the SCAI is to develop and revise practice guidelines for important car- (www.scai.org). Copies of the full text and the executive diovascular diseases and procedures. The Task Force is summary are available from the ACC, AHA, and the SCAI. pleased to have this guideline cosponsored by the Society for Cardiovascular Angiography and Interventions (SCAI). Elliott M. Antman, MD, FACC, FAHA Experts in the subject under consideration have been select- Chair, ACC/AHA Task Force on Practice Guidelines ed from all three organizations to examine subject-specific data and write guidelines. The process includes additional representatives from other medical practitioner and specialty 1. INTRODUCTION groups where appropriate. Writing groups are specifically charged to perform a formal literature review, weigh the The ACC/AHA Task Force on Practice Guidelines was strength of evidence for or against a particular treatment or formed to gather information and make recommendations procedure, and include estimates of expected health out- about appropriate use of technology for the diagnosis and comes where data exist. Patient-specific modifiers, comor- treatment of patients with cardiovascular disease. bidities, and issues of patient preference that might influence Percutaneous coronary interventions (PCIs) are an important the choice of particular tests or therapies are considered, as group of technologies in this regard. Although initially limit- well as frequency of follow-up and cost-effectiveness. When ed to balloon angioplasty and termed percutaneous translu- available, information from studies on cost will be consid- minal coronary angioplasty (PTCA), PCI now includes other ered; however, review of data on efficacy and clinical out- new techniques capable of relieving coronary narrowing. comes will be the primary basis for preparing recommenda- Accordingly, in this document, implantation of intracoronary tions in these guidelines. stents and other catheter-based interventions for treating The ACC/AHA Task Force on Practice Guidelines makes coronary atherosclerosis are considered components of PCI. every effort to avoid any actual, potential, or perceived con- In this context, PTCA will be used to refer to those studies flicts of interest that might arise as a result of an outside rela- using only balloon angioplasty, whereas PCI will refer to the tionship or personal interest of a member of the writing broader group of percutaneous techniques. These new tech- panel. Specifically, all members of the writing panel are nologies have impacted the effectiveness and safety profile asked to provide disclosure statements of all such relation- initially established for balloon angioplasty. Moreover, addi- ships that might be perceived as real or potential conflicts of tional experience has been gained in the use of adjunctive interest. These statements are reviewed by the parent task pharmacological treatment with glycoprotein (GP) IIb/IIIa force, reported orally to all members of the writing panel at receptor antagonists and the use of bivalirudin, thienopy- each meeting, and updated and reviewed by the writing com- ridines, and drug-eluting stents (DES). In addition, since mittee as changes occur. publication of the guidelines in 2001, greater experience in The practice guidelines produced are intended to assist the performance of PCI in patients with acute coronary syn- healthcare providers in clinical decision making by describ- dromes and in community hospital settings has been gained. ing a range of generally acceptable approaches for the diag- In view of these developments, an update of these guidelines
  • 4. ACC - www.acc.org Smith et al. 2005 AHA - www.americanheart.org 4 ACC/AHA/SCAI Practice Guidelines SCAI - www.scai.org is warranted. This document reflects the opinion of the are not available, there may be a very clear clinical consen- ACC/AHA/SCAI writing committee charged with updating sus that a particular test or therapy is useful and effective. the 2001 guidelines for PCI (1). In instances where recommendations of class III, level of Several issues relevant to the Writing Committee’s process evidence C, occur, it is recognized that the bases of these rec- and the interpretation of the guidelines have been noted pre- ommendations are opinion and the consensus of the writing viously and are worthy of restatement. First, PCI is a tech- group. In this setting, it is not unreasonable for clinical trials nique that has been continually refined and modified; hence, to be conducted to further investigate the validity of this con- continued, periodic guideline revision is anticipated. Second, sensus opinion. The schema for classification of recommen- these guidelines are to be viewed as broad recommendations dations and level of evidence is summarized in Table 1, to aid in the appropriate application of PCI. Under unique which also illustrates how the grading system provides an circumstances, exceptions may exist. These guidelines are estimate of the size of the treatment effect and an estimate of intended to complement, not replace, sound medical judg- the certainty of the treatment effect. ment and knowledge. They are intended for operators who The committee conducted comprehensive searching of the possess the cognitive and technical skills for performing PCI scientific and medical literature on PCI, with special empha- and assume that facilities and resources required to properly sis on randomized controlled trials and meta-analyses pub- perform PCI are available. As in the past, the indications are lished since 2001. In addition to broad-based searching on categorized as class I, II, or III on the basis of a multifactor- PCI, specific targeted searches were performed on the fol- ial assessment of risk and expected efficacy viewed in the lowing subtopics: catheter-based intervention, stents (drug- context of current knowledge and the relative strength of this eluting and bare-metal), cardiac biomarkers (e.g., creatine knowledge. kinase and troponins), pharmacological therapy (aspirin, These classes summarize the recommendations for proce- thienopyridines, GP IIb/IIIa inhibitors, heparin, and direct dures or treatments as follows: thrombin inhibitors), special populations (women, patients with diabetes, elderly), coronary artery bypass grafting Class I: Conditions for which there is evidence for (CABG), high-risk PCI, quality, outcomes, volume, left main and/or general agreement that a given proce- PCI (protected and unprotected), distal embolic protection, dure or treatment is beneficial, useful, and intravascular ultrasound (IVUS), fractional flow reserve effective. (FFR), vascular closure, and secondary prevention/risk fac- tor modification. The complete list of keywords is beyond Class II: Conditions for which there is conflicting evi- the scope of this section. The committee reviewed all com- dence and/or a divergence of opinion about piled reports from computerized searches and conducted the usefulness/efficacy of a procedure or additional searching by hand. Literature citations were gen- treatment. erally restricted to published manuscripts appearing in jour- Class IIa: Weight of evidence/opinion is in nals listed in Index Medicus. Because of the scope and favor of usefulness/efficacy. importance of certain ongoing clinical trials and other emerg- ing information, published abstracts were cited when they Class IIb: Usefulness/efficacy is less well were the only published information available. Additionally, established by evidence/opinion. the Committee reviewed and incorporated recommendations Class III: Conditions for which there is evidence and/or and/or text from published ACC/AHA or SCAI documents to general agreement that a procedure/treat- maintain consistency, as appropriate. ment is not useful/effective and in some cases Initially, this document describes the background informa- may be harmful. tion that forms the foundation for specific recommendations. Topics fundamental to coronary intervention are reviewed, In addition, the weight of evidence in support of the rec- followed by separate discussions relating to unique technical ommendation is listed as follows: and operational issues. This format is designed to enhance the usefulness of this document for the assessment and care • Level of Evidence A: Data derived from multiple random- of patients with coronary artery disease (CAD). Formal rec- ized clinical trials or meta-analyses. ommendations for the use of PCI according to clinical pres- entation are included in Section 5. A clear distinction is • Level of Evidence B: Data derived from a single random- drawn between the emergency use of PCI for patients with ized trial or nonrandomized studies. ST-segment elevation myocardial infarction (STEMI), • Level of Evidence C: Only consensus opinion of experts, termed “primary PCI,” and all other procedures, which are case studies, or standard-of-care. included under the term “elective PCI” (see Section 4.2 for further discussion). A recommendation with level of evidence B or C does not This committee includes cardiologists with and without imply that the recommendation is weak. Many important involvement in interventional procedures, and a cardiac sur- clinical questions addressed in the guidelines do not lend geon. This document was reviewed by 2 official reviewers themselves to clinical trials. Even though randomized trials nominated by ACC; 2 official reviewers nominated by AHA;
  • 5. Table 1. Applying Classification of Recommendations and Level of Evidence “Size of Treatment Effect” ACC - www.acc.org SCAI - www.scai.org AHA - www.americanheart.org *Data available from clinical trials or registries about the usefulness/efficacy in different sub-populations, such as gender, age, history of diabetes, history of prior MI, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomized trials are not available, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. Smith et al. 2005 ACC/AHA/SCAI Practice Guidelines †In 2003, the ACC/AHA Task Force on Practice Guidelines developed a list of suggested phrases to use when writing recommendations. All recommendations in this guideline have been written in full sentences that express a complete thought, such that a recommendation, even if separated and presented apart from the rest of the document (including headings above sets of recommendations), would still convey the full intent of the recommendation. It is hoped that this will increase readers’ comprehension of the guidelines and will allow queries at the individual recommendation level. 5
  • 6. ACC - www.acc.org Smith et al. 2005 AHA - www.americanheart.org 6 ACC/AHA/SCAI Practice Guidelines SCAI - www.scai.org 2 official reviewers nominated by SCAI; 1 official reviewer The value of coronary angioplasty was further defined by from the ACC/AHA Task Force on Practice Guidelines; and comparing its results to those of alternative methods of treat- 8 content reviewers, including members from the AHA ment. Randomized clinical trials have assessed the outcomes Committee on Diagnostic and Interventional Cardiac of patients treated by a strategy of initial angioplasty to one Catheterization and the ACCF Cardiac Catheterization and of medical therapy alone or to coronary artery bypass surgery Intervention Committee. (10-14). The results of these trials have clarified the utility of angioplasty in terms of effectiveness, complications, and 2. GENERAL CONSIDERATIONS AND patient selection. The technique of coronary angioplasty has BACKGROUND also been expanded by the development of devices that Coronary angioplasty was first introduced by Andreas replace or serve as adjuncts to the balloon catheter. These Gruentzig in 1977 (2) as a nonsurgical method for coronary “new devices” have been evaluated and have had a variable arterial revascularization. Fundamentally, the technique impact in enhancing the immediate- and long-term efficacy involved advancing a balloon-tipped catheter to an area of and safety of coronary angioplasty. The following section of coronary narrowing, inflating the balloon, and then removing this report expands on this background and describes the the catheter after deflation. Early reports demonstrated that practice of PCI as it is applied today. balloon angioplasty could reduce the severity of coronary Advances in coronary-based interventions, especially the stenosis and diminish or eliminate objective and subjective use of bare-metal stents (BMS) and drug-eluting stents manifestations of ischemia (3-5). Although angioplasty was (DES), have improved the efficacy and safety profile of per- clearly feasible and effective, the scope of coronary disease cutaneous revascularization observed for patients undergo- to be treated was quite narrow. Also, because angioplasty ing PTCA. For example, stents reduce both the acute risk of could result in sudden arterial occlusion and subsequent major complications and late-term restenosis. The success of myocardial infarction (MI), immediate access to coronary new coronary devices in meeting these goals is reflected in bypass surgery was essential (6). With experience and time, part by the rapid transition from the use of PTCA alone (less however, the cognitive and technical aspects as much as the than 30%) to the high use of PCI with stenting, which was equipment used to perform angioplasty became more greater than 70% by the late 1990s (Figure 1) (15). refined. Observational reports of large numbers of patients Atherectomy devices and stenting, associated with improved confirmed that coronary angioplasty could be applied to acute angiographic and clinical outcomes compared with broad groups of coronary patients with higher rates of suc- PTCA alone in specific subsets, continue to be applied to a cess and lower rates of complications than seen in initial wider patient domain that includes multivessel disease and experiences (7,8). More than 1 000 000 PCI procedures are complex coronary anatomy. However, strong evidence (level performed yearly in the United States (9), and it has been A data from multiple randomized clinical trials) is primarily estimated that nearly 2 000 000 procedures are performed available for stenting over PTCA in selected patients under- annually worldwide. going single-vessel PCI. Figure 1. Frequency of device use in the SCAI registry. Source data from Laskey et al. Catheter Cardiovasc Interv 2000;49:19-22 (15).
  • 7. ACC - www.acc.org AHA - www.americanheart.org Smith et al. 2005 SCAI - www.scai.org ACC/AHA/SCAI Practice Guidelines 7 The range of non-balloon revascularization technology Although the occurrence of emergency coronary artery approved by the Food and Drug Administration (FDA) for bypass surgery and death are easily identified end points, the use in native and/or graft coronary arteries includes balloon definition of procedure-related MI has been debated. The expandable stents, DES, extraction atherectomy, directional development of Q waves in addition to a threshold value of coronary atherectomy, rotational atherectomy, rheolytic creatine kinase (CK) elevation has been commonly used. thrombectomy catheter, proximal and distal embolic protec- Most agree that the definition of MI as put forth by the tion devices, excimer laser coronary atherectomy, and local ACC/European Society of Cardiology document on the rede- radiation devices to reduce in-stent restenosis (ISR) (16,17). finition of MI (21) should be the accepted standard. A variety of devices are under investigation, including new However, the clinical significance and definition of cardiac designs of balloon or self-expanding stents and mechanical biomarker elevations in the absence of Q waves remains the thrombectomy devices. This guideline update will focus on subject of investigation and debate (21a). Several reports the FDA-approved balloon-related and non-balloon coronary have identified non–Q-wave MIs with CK-MB elevations 3 revascularization devices. to 5 times the upper limit of normal as having clinical sig- nificance (22,23). One report suggests that a greater than 5 3. OUTCOMES times increase in CK-MB is associated with worsened out- The outcomes of PCI are measured in terms of success and come (24). Thus, this degree of increase in CK-MB without complications and are related to the mechanisms of the Q waves is considered by most to qualify as an associated employed devices, as well as the clinical and anatomic complication of PCI. Troponin T or I elevation occurs fre- patient-related factors. Complications can be divided into 2 quently after PCI. The timing of the peak elevation after PCI categories: (a) those common to all arterial catheterization is unclear (25). Minor elevations do not appear to have prog- procedures and (b) those related to the specific technology nostic value, whereas marked (greater than 5 times) eleva- used for the coronary procedure. Specific definitions of suc- tions are associated with worsened 1-year outcome (Table 2) cess and complications exist, and where appropriate, the def- (26-40). Troponin T or I elevation occurs more frequently initions used herein are consistent with the ACC-National than CK-MB increase after PCI (34). Cardiovascular Data Registry (NCDR®) Catheterization Laboratory Module version 3.0 (18). The committee recom- 3.1.3. Clinical Success mends such standards whenever feasible in order to accom- modate the common database for the assessment of out- In the short term, a clinically successful PCI includes comes. With increased operator experience, new technology, anatomic and procedural success with relief of signs and/or and adjunctive pharmacotherapy, the overall success and symptoms of myocardial ischemia after the patient recovers complication rates of angioplasty have improved. from the procedure. The long-term clinical success requires that the short-term clinical success remain durable and that 3.1. Definitions of PCI Success the patient have persistent relief of signs and symptoms of The success of a PCI procedure may be defined by angio- myocardial ischemia for more than 6 months after the proce- graphic, procedural, and clinical criteria. dure. Restenosis is the principal cause of lack of long-term clinical success when a short-term clinical success has been 3.1.1. Angiographic Success achieved. Restenosis is not considered a complication but rather an associated response to vascular injury. The inci- A successful PCI produces substantial enlargement of the dence of clinically important restenosis may be judged by the lumen at the target site. The consensus definition before the frequency with which subsequent revascularization proce- widespread use of stents was the achievement of a minimum dures are performed on target vessels after the index proce- stenosis diameter reduction to less than 50% in the presence dure. of grade 3 Thrombolysis In Myocardial Infarction (TIMI) flow (assessed by angiography) (1). However, with the advent of advanced adjunct technology, including coronary 3.2. Acute Outcome: Procedural Complications stents, a minimum stenosis diameter reduction to less than Class I 20% has been the clinical benchmark of an optimal angio- All patients who have signs or symptoms suggestive of graphic result. Frequently, there is a disparity between the MI during or after PCI and those with complicated visual assessment and computer-aided quantitative stenosis procedures should have CK-MB and troponin I or T measurement (19,20), and, thus, the determination of success measured after the procedure. (Level of Evidence: B) may be problematic when success rates are self-reported. Class IIa 3.1.2. Procedural Success Routine measurement of cardiac biomarkers (CK- A successful PCI should achieve angiographic success with- MB and/or troponin I or T) in all patients undergoing out major clinical complications (e.g., death, MI, emergency PCI is reasonable 8 to 12 hours after the procedure. coronary artery bypass surgery) during hospitalization (1,3). (Level of Evidence: C)
  • 8. Table 2. Incidence of Troponin Elevations After Percutaneous Coronary Intervention in the Published Literature First Author of % Positive Prognostic Study (Reference) n Marker Positive Definition Information 8 Hunt (29) 22 Troponin I 0 Greater than N/A 6 ng per mL Ravkilde (30) 23 Troponin T 13 Greater than N/A 0.12 ng per mL Karim (31) 25 Troponin T 44 Greater than N/A 0.2 ng per mL Smith et al. 2005 La Vecchia (32) 19 (Stent) Troponin T 37 cTnI; N/A N/A 25 (balloon PCI) and 21 cTnT troponin I 14 cTnI; 0 cTnT Johansen (33) 75 Troponin T 28 Greater than N/A 0.1 ng per mL ACC/AHA/SCAI Practice Guidelines Shyu (34) 59 (Stent) Troponin T 29 Greater than Significantly higher incidence of elevated cTnT in patients 61 (balloon PCI) 13 0.1 ng per mL undergoing stenting than angioplasty alone. Bertinchant (35) 105 Troponin I 22 Greater than No difference in incidence of recurrent angina, MI, cardiac death, 0.1 ng per mL or RR after 12 months between patients positive or negative for cTnI. Stenting not associated with more minor myocardial damage than angioplasty. Garbarz (36) 109 Troponin I 27 Greater than No association between post-PCI cTnI and adverse ischemic events. 0.3 ng per mL Fuchs (37) 1129 Troponin I 31 Greater than cTnT levels greater than 3× normal limit associated 0.15 ng per mL with increased risk of major in-hospital complications, but no association with adverse intermediate-term (8 months) clinical outcomes. Cantor (26) 481 Troponin I 48 overall; Greater than Significantly higher 90-day rates of MI and the composite of MI 26 after 1.5 ng per mL or death in patients with positive cTnI. excluding positive or unknown pre-PCI cTnI Wu (38) 98 Troponin T 26 Greater than At a mean of 77 months follow-up, no increase in risk of major adverse 0.1 ng per mL events detected in relation to post-PCI cTnT elevation. Kizer (27) 212 Troponin T 40 positive prior Greater than or Pre-PCI cTnT elevation was significantly related to event-free survival to PCI; 18 equal to during 6-year follow-up; in baseline negative patients, positive cTnT of baseline 0.1 ng per mL was the only independent predictor of major adverse events at 1 year; negative post-PCI elevations of cTnT greater than or equal to 5× normal was the were positive strongest long-term predictor of major adverse events at 6 years. post-PCI Ricciardi (39) 286 Troponin I 13.6 Greater than cTnI elevations greater than 3-fold care predictive of future major 2.3 ng per mL adverse cardiac events (MACE). Increased incidence of MACE is accounted for by higher rate of early RR and not late cardiac events. Kini (40) 2873 Troponin I 38.9 Greater than Neither cTnI peak elevations nor any subgroup predicted mid-term SCAI - www.scai.org AHA - www.americanheart.org ACC - www.acc.org 2 ng per mL mortality in low- to medium-risk patients. cTnI indicates cardiac troponin I; cTnT, cardiac troponin T; N/A, not applicable; PCI, percutaneous coronary intervention; and RR, repeat revascularization.
  • 9. ACC - www.acc.org AHA - www.americanheart.org Smith et al. 2005 SCAI - www.scai.org ACC/AHA/SCAI Practice Guidelines 9 Complications associated with PCI are similar to those Another study indicated that more extensive stent expan- resulting from diagnostic cardiac catheterization, but their sion resulted in CK release but did not increase adverse car- prevalence is more frequent. Complications have been cate- diac events (59). Accordingly, it is important to acknowledge gorized as major (death, MI, and stroke) or minor (transient that the significance of mild biomarker rises after clinically ischemic attack, access site complications, renal insufficien- successful PCI should be distinguished from situations cy, or adverse reactions to radiographic contrast). Additional wherein patients experience an unequivocal “clinical” infarc- specific complications include intracoronary thrombosis, tion manifested by chest pain and diagnostic ECG findings coronary perforation, tamponade, and arrhythmias. (60). Reported rates for death after diagnostic catheterization Routine measurement of CK-MB is advocated by some range from 0.08% to 0.14%, whereas analyses of large reg- (21) and actually mandated by certain healthcare systems. In istries indicate overall unadjusted in-hospital rates for PCI of this regard, the current Committee supports the recommen- 0.4% to 1.9% (Table 3) (41-52). This range is greatly influ- dations of the 2001 Guidelines and recommends that all enced by the clinical indication for which PCI is performed, patients who have signs or symptoms suggestive of MI dur- with the highest mortality rates occurring among patients ing or after PCI and those with complicated procedures with STEMI and cardiogenic shock. Death in such patients should have CK-MB and troponin I or T measured after the may not be a direct result of the PCI procedure but rather a procedure. In addition, the Committee recommends that rou- consequence of the patient’s underlying illness. For example, tine measurement of cardiac biomarkers (CK-MB and/or tro- in a combined analysis of PCI as primary reperfusion thera- ponin I or T) in every patient undergoing PCI is reasonable 8 py for STEMI, the short-term mortality rate was 7% (53). to 12 h after the procedure. In such patients, a new CK-MB Even after exclusion of patients with cardiogenic shock, in- or troponin I or T rise greater than 5 times the upper limit of hospital mortality was 5%. normal would constitute a clinically significant periproce- Myocardial infarction can be a direct result of PCI, most dural MI. commonly due to abrupt coronary occlusion or intracoronary The need to perform emergency coronary artery bypass embolization of obstructive debris. Determining and com- surgery (CABG) has been considered as a potential compli- paring the incidence of MI after PCI is difficult because the cation of PCI. Typically, CABG is performed as a rescue definition of MI as a result of PCI is controversial. The con- revascularization procedure to treat acute ischemia or infarc- ventional definition requires 2 of the following: a) prolonged tion resulting from PCI-induced acute coronary occlusion. In chest discomfort or its equivalent; b) development of patho- the era of balloon angioplasty, the rate of emergency CABG logic Q waves; and c) rise in serum cardiac biomarkers above was 3.7% (49). In a more contemporary time period, with the a critical level. Rates of periprocedural MI using this defini- availability of stents, the reported rate was 0.4% among a tion have ranged from 0.4% to 4.9%. Using a consistent def- similar cohort of patients. inition for MI, the incidence of this complication has declined approximately 50% with the routine use of intra- Various definitions have been proposed for stroke. A com- coronary stents (21,21a,50). mon feature to definitions has been a loss of neurologic func- More recently, an isolated rise and fall in either CK-MB or tion of vascular cause that lasts more than 24 h. More recent- troponin is considered to be a marker of myocardial necrosis ly, attention has been directed to refining the definition of (21). The relationship between cardiac biomarker elevation transient ischemic attack (TIA), which indirectly broadens and myocardial cell death and evidence of subendocardial that of stroke (61). The time-based definition of a TIA is a infarction on magnetic resonance imaging (MRI) support sudden, focal neurologic deficit that lasts less than 24 h that this position (54,55). Furthermore, large rises in cardiac bio- is of presumed vascular origin and confined to an area of the markers are associated with an increased risk for late death brain or eye perfused by a specific artery. The new definition (26,56,57). Whether death in such patients is a consequence of TIA is a brief episode of neurologic dysfunction caused by of the myonecrosis or a marker of patients who are at brain or retinal ischemia, with clinical symptoms typically increased risk for death because of more advanced coronary lasting less than 1 hour and without evidence of infarction. disease is unclear. Complicating our understanding of the Presence of cerebral infarction by imaging techniques con- implications of this definition is the very frequently observed stitutes evidence of stroke regardless of the duration of mild to modest elevation of serum CK-MB among patients symptoms. with apparently uncomplicated PCI. When troponin is meas- Bleeding is a complication of increasing concern with the ured after PCI, more than 70% of patients exhibit elevated more frequent use of potent antithrombin and antiplatelet values after an otherwise successful intervention (58). Such agents. A frequently used definition for bleeding developed patients may have no symptoms or electrocardiographic by the TIMI group includes classification as major, moder- (ECG) abnormalities to suggest ischemia yet are “enzyme ate, or minor. Major bleeding is defined as intracranial, positive.” One study has suggested a postprocedural increase intraocular, or retroperitoneal hemorrhage or any hemor- in troponin T of 5 times normal is predictive for adverse rhage requiring a transfusion or surgical intervention or that events at 6 years. The long-term prognostic significance of results in a hematocrit decrease of greater than 15% or hemo- smaller postprocedural troponin T elevations awaits further globin decrease of greater than 5 g per dL (62). Episodes of investigation (27) (Table 2) (26-40). hemorrhage of lesser magnitude would fall into the moder-
  • 10. 10 Smith et al. 2005 Table 3. Unadjusted In-Hospital Outcome Trends After Percutaneous Coronary Interventions Clinical Success, In-Hospital Q-Wave Emergency Registry Years Reference n % Mortality, % MI, % CABG, % NHLBI (I)‡ 1977-1981 (41) 3079* 61 1.2 NR 5.8 ACC/AHA/SCAI Practice Guidelines NHLBI (II)§ 1985-1986 (41) 2311* 78 1.0 4.8 5.8 BARI Registry|| 1988-1991 (42) 1189* NR 0.7 2.8 4.1 Northern New England¶ 1990-1993 (43) 13 014† 88.8 1.0 2.4 2.2 SCAI# 1990-1994 (44) 4366† 91.5 2.5 NR 3.4 NACI** 1990-1994 (45) 4079* NR 1.6 1.6 1.9 NY State Database 1991-1994 (46,47) 62 670* NR 0.9 NR 3.4 Northern New England¶ 1994-1995 (43) 7248† 89.2 1.1 2.1 2.3 NCN 1994-1997 (48) 76 904† NR 1.3 NR 1.7 Northern New England¶ 1995-1997 (43) 14 490† 91.5 1.2 2.0 1.3 NHLBI Dynamic Registry‡‡ 1997-1998 (49) 1559* 92 1.9 2.8 0.4 NHLBI Dynamic 1997-1999 (50) 857 91 0.9 0.8 1.9 ACC-NCDR 1998-2000 (51) 100 292 96.5 1.4 0.4 1.9 NY State Database 1997-2000 (52) 22 102 NR 0.68 NR NR CABG indicates coronary artery bypass graft surgery; MI, myocardial infarction; NACI, New Approaches in Coronary Interventions; NCN, National Cardiovascular Network; and NR, not reported. *N indicates number of patients. †N indicates number of procedures. ‡In NHLBI (I), emergency CABG was defined as in-hospital CABG. §In NHLBI (II), MI was defined as the presence of at least 2 of the 3 criteria: clinical symptoms, Q waves on ECG (Minnesota code), or elevated cardiac enzyme level (double the normal levels for CK or its MB fraction without Q waves). Emergency CABG was defined as in-hospital CABG. ||In BARI, MI was defined as the appearance of ECG changes (new pathologic Q waves) supported by abnormal CK-MB elevations. ¶In Northern New England, a new MI was defined as a clinical event, ECG changes, and a creatinine phosphokinase rise at least 2 times normal levels with positive isozymes. Emergency CABG was defined as surgery per- formed to treat acute closure, unstable angina, or congestive heart failure requiring intravenous nitroglycerin or ABP, or tamponade resulting from the intervention. #In SCAI, a new MI was defined as any significant infarction (greater than 3 times normal rise in MB fraction). **In NACI, MI was defined as a Q-wave MI. ††MI was defined as 2 or more of the following: 1) typical chest pain greater than 20 min not relieved by nitroglycerin; 2) serial ECG recordings showing changes from baseline or serially in ST-T and/or Q waves in at least 2 contiguous leads; or 3) serum enzyme elevation of CK-MB greater than 5% of total CK (total CK more than 2 times normal; lactate dehydrogenase subtype 1 greater than lactate dehydrogenase subtype 2). SCAI - www.scai.org AHA - www.americanheart.org ACC - www.acc.org
  • 11. ACC - www.acc.org AHA - www.americanheart.org Smith et al. 2005 SCAI - www.scai.org ACC/AHA/SCAI Practice Guidelines 11 ate/minor categories. A listing of other bleeding classifica- In addition to multivessel disease, other clinical factors tions has been developed for use by the ACC-NCDR® (18). adversely impact late mortality. In randomized patients with treated diabetes undergoing PTCA in BARI, the 5-year sur- 3.3. Acute Outcome: Success Rates vival was 65.5%, and the cardiac mortality rate was 20.6% compared with 5.8% in patients without treated diabetes Success has been described on both a lesion and patient (67), although among eligible but not randomized diabetic basis. In early studies of PTCA, lesion success is defined as patients treated with PTCA, the 5-year cardiac mortality rate an absolute 20% reduction in lesion severity with final steno- was 7.5% (68). In the 1985-1986 NHLBI PTCA Registry, 4- sis less than 50%. When describing the results of multiple year survival was significantly lower in women (89.2%) than attempted lesions, success is classified as either partial (some in men (93.4%) (69). In addition, although LV dysfunction but not all attempted lesions successfully treated) or total was not associated with an increase in in-hospital mortality (each attempted lesion successfully treated). Procedural suc- or nonfatal MI in patients undergoing PTCA in the same reg- cess is defined as the achievement of either partial or total istry, it was an independent predictor of a higher long-term angiographic success without death, MI, or emergency mortality (70). CABG (49). A major determinant of event-free survival after coronary Reported rates of angiographic success now range between intervention is the incidence of restenosis, which had, until 82% and 98% depending on the device used and the types of the development of stents, remained fairly constant despite lesions attempted. Formal comparisons demonstrate that suc- multiple pharmacologic and mechanical approaches to limit cess rates are now higher (91% to 92%) in the era of new this process (Table 4) (71-95). The incidence of restenosis technology, which includes stents and contemporary drug after coronary intervention varies depending on the defini- therapies, than in the era of conventional balloon angioplas- tion, i.e., whether clinical or angiographic restenosis or tar- ty (72% to 74%) (49). The types of lesions attempted strong- get-vessel revascularization is measured (96). Data from ly influence success rates. The chance of dilating a chronic multiple randomized clinical trials and prospective registries total occlusion averages 65%, and specific clinical and suggest that DES incorporating either rapamycin or paclitax- anatomic factors have been identified that affect this rate el with a timed-release polymer are associated with a reduc- (63). Quite different are the success rates for total occlusions tion in restenosis rates to less than 10% across a wide spec- associated with STEMI. Success rates over 90% can be trum of clinical and angiographic subsets. expected in this subgroup (64). The pathogenesis of the response to mechanical coronary With an increase in angiographic success rates and a injury is thought to relate to a combination of growth factor decline in periprocedural MI and the need for emergency stimulation, smooth muscle cell migration and proliferation, CABG, procedural success rates have risen from a range of organization of thrombus, platelet deposition, and elastic 80% to 85% to a range of 90% to 95% (Table 3) (41-52). recoil (97,98). In addition, change in vessel size (or lack of compensatory enlargement) has been implicated (99). It has 3.4. Long-Term Outcome and Restenosis been suggested that attempts to reduce restenosis have failed in part because of lack of recognition of the importance of Although improvements in technology, such as stents, have this factor (100). Although numerous definitions of resteno- resulted in an improved acute outcome of the procedure, the sis have been proposed, greater than 50% diameter stenosis impact of these changes on long-term (5 to 10 years) out- at follow-up angiography has been most frequently used come may be less dramatic because factors such as advanced because it was thought to correlate best with maximal flow age, reduced left ventricular (LV) function, and progression and therefore ischemia. However, it is now recognized that of complex multivessel disease in patients currently under- the response to arterial injury is a continuous rather than a going PCI may have a more important influence. In addition, dichotomous process, occurring to some degree in all available data on long-term outcome are mostly limited to patients (101). Therefore, cumulative frequency distributions patients undergoing PTCA. Ten-year follow-up of the initial of the continuous variables of minimal lumen diameter or cohort of patients treated with PTCA revealed an 89.5% sur- percent diameter stenosis are frequently used to evaluate vival rate (95% in patients with single-vessel disease, 81% in restenosis in large patient populations (102) (Figure 2) (80). patients with multivessel disease) (65). In patients undergo- Although multiple clinical factors (diabetes, unstable angi- ing PTCA within the 1985-1986 National Heart, Lung, and na [UA]/NSTEMI, STEMI, and prior restenosis) (103,104), Blood Institute (NHLBI) PTCA Registry (66), 5-year sur- angiographic factors (proximal left anterior descending vival was 92.9% for patients with single-vessel disease, artery [LAD], small vessel diameters, total occlusion, long 88.5% for those with 2-vessel disease, and 86.5% for those lesion length, and saphenous vein grafts [SVGs]) (105), and with 3-vessel disease. In patients with multivessel disease procedural factors (higher postprocedure percent diameter undergoing PTCA in the Bypass Angioplasty stenosis, smaller minimal lumen diameter, and smaller acute Revascularization Investigation (BARI) (10), 5-year survival gain) (102) have been associated with an increased incidence was 86.3%, and infarct-free survival was 78.7%. of restenosis, the ability to integrate these factors and predict Specifically, 5-year survival was 84.7% in patients with 3- the risk of restenosis in individual patients after the proce- vessel disease and 87.6% in patients with 2-vessel disease. dure remains difficult. The most promising potential
  • 12. ACC - www.acc.org Smith et al. 2005 AHA - www.americanheart.org 12 ACC/AHA/SCAI Practice Guidelines SCAI - www.scai.org Table 4. Selected Trials of Pharmacological and Mechanical Approaches to Limit Restenosis Restenosis Rate, % Study Year Reference n Agent Placebo or Control Agent Schwartz 1988 (71) 376 Aspirin and dipyridamole 39 38 Ellis 1989 (72) 416 Heparin 37 41 Pepine 1990 (73) 915 Methylprednisolone 39 40 CARPORT 1991 (74) 649 Vapiprost 19 21 O’Keefe 1992 (75) 197 Colchicine 22 22 MERCATOR 1992 (76) 735 Cilazapril 28 28 CAVEAT* 1993 (77) 500 DCA versus PTCA 57 50 CCAT 1993 (78) 136 DCA versus PTCA 43 46 Serruys 1993 (79) 658 Ketanserin 32 32 BENESTENT* 1994 (80) 520 Stent versus PTCA 32 22 ERA 1994 (81) 458 Enoxaparin 51 52 Leaf 1994 (82) 551 Fish oil 46 52 STRESS* 1994 (83) 410 Stent versus PTCA 42 32 Weintraub 1994 (84) 404 Lovastatin 42 39 BOAT* 1998 (85) 492 DCA versus PTCA 40 31 Wantanabe* 1996 (86) 118 Probucol 40 20 Tardif* 1997 (87) 317 Probucol 39 21 BENESTENT II* 1998 (88) 823 Stent versus PTCA 31 17 TREAT* 1999 (89) 255 Tranilast 39 18 PRESTO* 2000 (90) 192 DCA and Tranilast 26 11 ARTIST* 2002 (91) 298 Rotablation (in-stent) 51 65 versus PTCA START* 2002 (92) 476 Radiation (in-stent) 45 29 SIRIUS* 2003 (93) 1058 Sirolimus-coated stent versus 36 9 bare stent TAXUS-IV* 2004 (94) 1314 Paclitaxel-coated stent versus 27 8 bare stent RESCUT 2004 (95) 428 Cutting balloon (in-stent) 31 30 versus PTCA DCA indicates directional coronary atherectomy; n, number of patients; and PTCA, percutaneous transluminal coronary angioplasty. *P less than 0.05. approaches to favorably impact the restenosis process are clopidogrel. The development of DES has significantly stents and, more recently, DES and catheter-based radiation. reduced the rate of ISR (see Section 7.3.6 for full discus- More than 6300 patients have been studied in 12 randomized sion). clinical trials to assess the efficacy of PTCA versus stents to reduce restenosis (Table 5) (80,83,88,106-114). 3.5. Predictors of Success/Complications The pivotal BENESTENT (BElgian NEtherlands STENT 3.5.1. Lesion Morphology and Classification study) (80) and STRESS (STent REStenosis Study) trials (83) documented that stents significantly reduce angiograph- Target lesion anatomic factors related to adverse outcomes ic restenosis compared with balloon angioplasty (BENES- have been widely examined. Lesion morphology and TENT: 22% vs 32%; STRESS: 32% vs 42%, respectively). absolute stenosis severity were identified as the prominent These results were further corroborated in the BENESTENT predictors of immediate outcome during PTCA in the II trial, in which the angiographic restenosis rate was reduced prestent era (118,119). Abrupt vessel closure, due primarily by almost half (from 31% to 16% in patients treated with bal- to thrombus or dissection, was reported in 3% to 8% of loon angioplasty versus heparin-coated stents, respectively) patients and was associated with certain lesion characteris- (88). tics (120-122). The risk of PTCA in the prestent era relative In addition, randomized studies in patients with ISR have to anatomic subsets has been identified in previous NHLBI shown that both intracoronary gamma and beta radiation sig- PTCA Registry data (7) and by the ACC/AHA Task Force on nificantly reduced the rate of subsequent angiographic and Practice Guidelines (1,123). The lesion classification based clinical restenosis by 30% to 50% (92,115-117). Late suba- on severity of characteristics proposed in the past (123-125) cute thrombosis was observed in some of these series (117), has been principally altered using the present PCI tech- but this syndrome has resolved with judicious use of stents niques, which capitalize on the ability of stents to manage and extended adjunct antiplatelet therapy with ticlopidine or initial and subsequent complications of coronary interven-
  • 13. ACC - www.acc.org AHA - www.americanheart.org Smith et al. 2005 SCAI - www.scai.org ACC/AHA/SCAI Practice Guidelines 13 Figure 2. Balloon stent vs balloon angioplasty in coronary artery disease. Cumulative frequency distribution curves for the 2 study groups, showing minimum lumen diameters measured before and after intervention and follow-up (B), the percentage of stenosis at follow-up, and the percentage of patients with clinical end points. Significant differences were apparent that consistently favored the stent group over the angioplasty group with respect to the increased minimal lumen diameter at intervention (A) and follow-up (B), the percentage of stenosis at follow-up (C), and the incidence of major clinical events (D). The vertical dashed line in D indicated the end of the study. Reprinted with permission from Serruys et al. N Engl J Med 1994;331:489-95 (80). Copyright 2004 Massachusetts Medical Society. All rights reserved. tions (126). As a result, the Committee has revised the previ- the operator classified the lesion after finishing the case and ous ACC/AHA lesion classification system to reflect high- knowing whether the case was successful or had complica- risk (at least 1 type C lesion characteristic) and non–high- tions. No prospective studies using core laboratory analysis risk (no type C lesion characteristic) lesions (Table 6) in have validated this system. Nonetheless, the SCAI classifi- accordance with the PCI Clinical Data Standards from the cation system utilizing vessel patency in addition to C and ACC-NCDR® (18). Studies (127-130) have confirmed that non-C class appears promising to categorize the risk of suc- complex coronary lesions remain predictive of adverse cess and complications with PCI. events after PCI. However, although the risk of restenosis and technical failure remains high for chronic total occlu- 3.5.1.1. Clinical Factors sions, the risk of acute complications is not increased. Coexistent clinical conditions can increase the complication The SCAI proposed a new lesion classification using 7 rates for any given anatomic risk factor. For example, com- lesion characteristics (131). This system dichotomizes plications occurred in 15.4% of patients with diabetes versus lesions by the presence or absence of a type C characteristic 5.8% of patients without diabetes undergoing balloon angio- and vessel patency versus total occlusion, yielding 4 lesion plasty in a multicenter experience (119,122). Several studies classes (Table 7) (132). Utilizing data from the voluntary have reported specific factors associated with increased risk ACC-NCDR®, the SCAI group presented analyses that of adverse outcome after PTCA. These factors include showed that the more simplified SCAI lesion classification advanced age, female gender, UA, congestive heart failure provided better discrimination for success and complications (CHF), diabetes, and multivessel CAD (10,118,119,127- than the ACC/AHA lesion classification system (132,133). 130,134,135). Elevated baseline C-reactive protein (CRP) The SCAI lesion classification system was validated from has recently also been shown to be predictive of 30-day death a voluntary registry, which imposes a potential bias because and MI (128,136). Other markers of inflammation, such as
  • 14. 14 Smith et al. 2005 Table 5. Studies Comparing Balloon Angioplasty with Stents for Native Coronary Artery Lesions Follow-Up, n, Stent/ Angiographic Restenosis, % TVR, % Death, % Study (Ref) Year mo Angioplasty Stent Angioplasty P value Stent Angioplasty P value Stent Angioplasty P value ACC/AHA/SCAI Practice Guidelines STRESS (83) 1994 6 205/202 31.6 42.1 0.046 10.2 15.4 0.06 1.5 1.5 NS BENESTENT (80,107) 1996 7/12* 259/257 22 32 0.02 10 21 0.001 1.2 0.8 NS Versaci et al. (108) 1997 12 60/60 19 40 0.02 6.6 22 NA NA NA NA STRESS II (109) 1998 12 100/89 NA NA NA 10 20 NA 17|| 34|| NA BENESTENT II (88) 1998 6 413/410 16 31 Less than 8† 13.7 0.02 0.2% 0.5% NS 0.001 OCBAS (110) 1998 7 57/59 18.8 16.6 NA 17.5 9.2 NA 0 1.6 NS EPISTENT (111,112)‡ 1998 6 794/796 NA NA NA 8.7 15.4 Less than 0.5 1.8 0.02 0.001 START (113) 1999 6/48§ 229/223 22 37 Less than 12 24.6 Less than 2.7 2.4 NS 0.002 0.002 OPUS (114) 2000 6 479 (Overall) NA NA NA 3.0 10.1 0.003 0.4 1.2 NS mo indicates months; NA, data not reported for that category, NS, not significant; and TVR, target vessel revascularization. Data are for lesions in coronary arteries with vessel diameter greater than or equal to 3.0 mm. *6-7 months angiographic follow-up and 12 months clinical follow-up. †Any repeat procedure. ‡Stent plus abciximab versus percutaneous transluminal angioplasty plus abciximab. §6 months angiographic follow-up and 48 months clinical follow-up. ||End point of death/any MI/CABG/target lesion percutaneous transluminal angioplasty. Modified with permission from AI SJ et al. JAMA 2000;284:1828-36 (106). SCAI - www.scai.org AHA - www.americanheart.org ACC - www.acc.org